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Article ; Online: Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.

Kayentao, Kassoum / Ongoiba, Aissata / Preston, Anne C / Healy, Sara A / Hu, Zonghui / Skinner, Jeff / Doumbo, Safiatou / Wang, Jing / Cisse, Hamidou / Doumtabe, Didier / Traore, Abdrahamane / Traore, Hamadi / Djiguiba, Adama / Li, Shanping / Peterson, Mary E / Telscher, Shinyi / Idris, Azza H / Adams, William C / McDermott, Adrian B /

The New England journal of medicine

2024 Volume 390, Issue 17, Page(s) 1549–1559

Abstract: Background: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled : Methods: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 ... ...

Abstract	Background: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled Methods: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first Results: No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B. Conclusions: Subcutaneous administration of L9LS to children was protective against
MeSH term(s)	Humans ; Malaria, Falciparum/prevention & control ; Injections, Subcutaneous ; Female ; Child ; Male ; Plasmodium falciparum/immunology ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Double-Blind Method ; Mali ; Animals ; Dose-Response Relationship, Drug ; Kaplan-Meier Estimate ; Adult
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2024-04-26
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Clinical Trial, Phase II ; Research Support, Non-U.S. Gov't ; Multicenter Study ; Research Support, N.I.H., Extramural
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2312775
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Article ; Online: Phase 1 trial evaluating safety and pharmacokinetics of HIV-1 broadly neutralizing mAbs 10E8VLS and VRC07-523LS.

Awan, Seemal F / Pegu, Amarendra / Strom, Larisa / Carter, Cristina A / Hendel, Cynthia S / Holman, LaSonji A / Costner, Pamela J / Trofymenko, Olga / Dyer, Renunda / Gordon, Ingelise J / Rothwell, Ro Shauna S / Hickman, Somia P / Conan-Cibotti, Michelle / Doria-Rose, Nicole A / Lin, Bob C / O'Connell, Sarah / Narpala, Sandeep R / Almasri, Cassandra G / Liu, Cuiping /

Ko, Sungyoul / Kwon, Young D / Namboodiri, Aryan M / Pandey, Janardan P / Arnold, Frank J / Carlton, Kevin / Gall, Jason G / Kwong, Peter D / Capparelli, Edmund V / Bailer, Robert T / McDermott, Adrian B / Chen, Grace L / Koup, Richard A / Mascola, John R / Coates, Emily E / Ledgerwood, Julie E / Gaudinski, Martin R

JCI insight

2024 Volume 9, Issue 7

Abstract: BACKGROUNDBroadly neutralizing monoclonal antibodies (bNAbs) represent a promising strategy for HIV-1 immunoprophylaxis and treatment. 10E8VLS and VRC07-523LS are bNAbs that target the highly conserved membrane-proximal external region (MPER) and the CD4- ...

Abstract	BACKGROUNDBroadly neutralizing monoclonal antibodies (bNAbs) represent a promising strategy for HIV-1 immunoprophylaxis and treatment. 10E8VLS and VRC07-523LS are bNAbs that target the highly conserved membrane-proximal external region (MPER) and the CD4-binding site of the HIV-1 viral envelope glycoprotein, respectively.METHODSIn this phase 1, open-label trial, we evaluated the safety and pharmacokinetics of 5 mg/kg 10E8VLS administered alone, or concurrently with 5 mg/kg VRC07-523LS, via s.c. injection to healthy non-HIV-infected individuals.RESULTSEight participants received either 10E8VLS alone (n = 6) or 10E8VLS and VRC07-523LS in combination (n = 2). Five (n = 5 of 8, 62.5%) participants who received 10E8VLS experienced moderate local reactogenicity, and 1 participant (n = 1/8, 12.5%) experienced severe local reactogenicity. Further trial enrollment was stopped, and no participant received repeat dosing. All local reactogenicity resolved without sequelae. 10E8VLS retained its neutralizing capacity, and no functional anti-drug antibodies were detected; however, a serum t1/2 of 8.1 days was shorter than expected. Therefore, the trial was voluntarily stopped per sponsor decision (Vaccine Research Center, National Institute of Allergy and Infectious Diseases [NIAID], NIH). Mechanistic studies performed to investigate the underlying reason for the reactogenicity suggest that multiple mechanisms may have contributed, including antibody aggregation and upregulation of local inflammatory markers.CONCLUSION10E8VLS resulted in unexpected reactogenicity and a shorter t1/2 in comparison with previously tested bNAbs. These studies may facilitate identification of nonreactogenic second-generation MPER-targeting bNAbs, which could be an effective strategy for HIV-1 immunoprophylaxis and treatment.TRIAL REGISTRATIONClinicaltrials.gov, accession no. NCT03565315.FUNDINGDivision of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH.
MeSH term(s)	Humans ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; HIV Antibodies ; HIV-1 ; Broadly Neutralizing Antibodies/pharmacology ; HIV Seropositivity ; Antibodies, Monoclonal/pharmacology
Chemical Substances	HIV Antibodies ; Broadly Neutralizing Antibodies ; Antibodies, Monoclonal
Language	English
Publishing date	2024-04-08
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ISSN	2379-3708
ISSN (online)	2379-3708
DOI	10.1172/jci.insight.175375
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Article ; Online: Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants.

Muňoz, Flor M / Swamy, Geeta K / Hickman, Somia P / Agrawal, Sapeckshita / Piedra, Pedro A / Glenn, Gregory M / Patel, Nita / August, Allison M / Cho, Iksung / Fries, Louis

The Journal of infectious diseases

2019 Volume 220, Issue 11, Page(s) 1802–1815

Abstract: Background: Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract disease and hospitalization worldwide.: Methods: Safety and immunogenicity of RSV fusion (F) protein nanoparticle vaccine or placebo were evaluated ... ...

Abstract	Background: Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract disease and hospitalization worldwide. Methods: Safety and immunogenicity of RSV fusion (F) protein nanoparticle vaccine or placebo were evaluated in 50 healthy third-trimester pregnant women. Assessments included vaccine tolerability and safety in women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and post partum. Results: The vaccine was well tolerated; no meaningful differences in pregnancy or infant outcomes were observed between study groups. RSV-specific antibody levels increased significantly among vaccine recipients, including responses competitive with well-described monoclonal antibodies specific for multiple RSV neutralizing epitopes. No significant antibody increase was seen among placebo recipients, although a shallow upward trend across the RSV season was noted. Transplacental antibody transfer was 90%-120% across assays for infants of vaccinated women. Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days. Half-lives of RSV-specific antibodies in infants approximated 40 days. There was no evidence of severe RSV disease in infants of vaccinated mothers. Conclusions: Data from this phase 2 study support a maternal immunization strategy to protect infants from RSV disease. Clinical trials registration: NCT02247726.
MeSH term(s)	Adolescent ; Adult ; Antibodies, Viral/blood ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Healthy Volunteers ; Humans ; Infant ; Male ; Placebos/administration & dosage ; Pregnancy ; Pregnancy Trimester, Third ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Vaccines/administration & dosage ; Respiratory Syncytial Virus Vaccines/adverse effects ; Respiratory Syncytial Virus Vaccines/immunology ; Vaccines, Virus-Like Particle/administration & dosage ; Vaccines, Virus-Like Particle/adverse effects ; Vaccines, Virus-Like Particle/immunology ; Viral Fusion Proteins/immunology ; Young Adult
Chemical Substances	Antibodies, Viral ; F protein, human respiratory syncytial virus ; Placebos ; Respiratory Syncytial Virus Vaccines ; Vaccines, Virus-Like Particle ; Viral Fusion Proteins
Language	English
Publishing date	2019-08-08
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiz390
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Article ; Online: Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial.

Mwesigwa, Betty / Houser, Katherine V / Hofstetter, Amelia R / Ortega-Villa, Ana M / Naluyima, Prossy / Kiweewa, Francis / Nakabuye, Immaculate / Yamshchikov, Galina V / Andrews, Charla / O'Callahan, Mark / Strom, Larisa / Schech, Steven / Anne Eller, Leigh / Sondergaard, Erica L / Scott, Paul T / Amare, Mihret F / Modjarrad, Kayvon / Wamala, Amir / Tindikahwa, Allan /

Musingye, Ezra / Nanyondo, Jauhara / Gaudinski, Martin R / Gordon, Ingelise J / Holman, LaSonji A / Saunders, Jamie G / Costner, Pamela J M / Mendoza, Floreliz H / Happe, Myra / Morgan, Patricia / Plummer, Sarah H / Hickman, Somia P / Vazquez, Sandra / Murray, Tamar / Cordon, Jamilet / Dulan, Caitlyn N M / Hunegnaw, Ruth / Basappa, Manjula / Padilla, Marcelino / Gajjala, Suprabhath R / Swanson, Phillip A / Lin, Bob C / Coates, Emily E / Gall, Jason G / McDermott, Adrian B / Koup, Richard A / Mascola, John R / Ploquin, Aurélie / Sullivan, Nancy J / Kibuuka, Hannah / Ake, Julie A / Ledgerwood, Julie E

The Lancet. Infectious diseases

2023 Volume 23, Issue 12, Page(s) 1408–1417

Abstract: Background: Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and ... ...

Abstract	Background: Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and therapeutics specific for Zaire Ebola virus have been approved for use during outbreak situations, Sudan Ebola virus is an antigenically distinct virus with no approved vaccines available. Methods: In this phase 1, open-label, dose-escalation trial we evaluated the safety, tolerability, and immunogenicity of a monovalent chimpanzee adenovirus 3 vaccine against Sudan Ebola virus (cAd3-EBO S) at Makerere University Walter Reed Project in Kampala, Uganda. Study participants were recruited from the Kampala metropolitan area using International Review Board-approved written and electronic media explaining the trial intervention. Healthy adults without previous receipt of Ebola, Marburg, or cAd3 vectored-vaccines were enrolled to receive cAd3-EBO S at either 1 × 10 Findings: 40 healthy adults were enrolled between July 22 and Oct 1, 2019, with 20 receiving 1 × 10 Interpretation: The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset and durability of the vaccine-induced antibodies make this vaccine a strong candidate for emergency deployment in Sudan Ebola virus outbreaks. Funding: National Institutes of Health via interagency agreement with Walter Reed Army Institute of Research.
MeSH term(s)	Animals ; Humans ; Adult ; Hemorrhagic Fever, Ebola/prevention & control ; Ebola Vaccines ; Pan troglodytes ; Uganda ; Sudan ; Ebolavirus/genetics ; Antibodies, Viral ; Adenoviruses, Simian/genetics ; Adenoviridae/genetics ; Glycoproteins ; Immunogenicity, Vaccine ; Double-Blind Method
Chemical Substances	Ebola Vaccines ; Antibodies, Viral ; Glycoproteins
Language	English
Publishing date	2023-08-03
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(23)00344-4
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Article: Homeostatic T cell proliferation as a barrier to T cell tolerance.

Hickman, Somia P / Turka, Laurence A

Philosophical transactions of the Royal Society of London. Series B, Biological sciences

2005 Volume 360, Issue 1461, Page(s) 1713–1721

Abstract: The maintenance of T cell numbers in the periphery is mediated by distinct homeostatic mechanisms that ensure the proper representation of naïve and memory T cells. Homeostatic proliferation refers to the process by which T cells in lymphopenic hosts ... ...

Abstract	The maintenance of T cell numbers in the periphery is mediated by distinct homeostatic mechanisms that ensure the proper representation of naïve and memory T cells. Homeostatic proliferation refers to the process by which T cells in lymphopenic hosts divide in the absence of cognate antigen to reconstitute the peripheral lymphoid compartment. During this process T cells acquire effector-memory like properties, including the ability to respond to low doses of antigen in the absence of CD28 costimulation. Furthermore, this capacity is retained long after proliferation has ceased. Accumulating data implicates homeostatic proliferation in autoimmune diseases and transplant rejection, and suggests that it may represent a barrier to tolerance in protocols that use T cell depletion. Implementing combination therapies that aim to promote the development and expansion of regulatory T cell populations while specifically targeting alloresponsive T cells may be the soundest approach to attaining allograft tolerance in the aftermath of T cell depletion and homeostatic proliferation.
MeSH term(s)	Cell Differentiation/immunology ; Cell Proliferation ; Homeostasis/immunology ; Humans ; Immune Tolerance/immunology ; Immunotherapy/methods ; Models, Immunological ; T-Lymphocyte Subsets/immunology
Language	English
Publishing date	2005-09-29
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	208382-6
ISSN	1471-2970 ; 0962-8436 ; 0080-4622 ; 0264-3839
ISSN (online)	1471-2970
ISSN	0962-8436 ; 0080-4622 ; 0264-3839
DOI	10.1098/rstb.2005.1699
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Article ; Online: Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs.

Glenn, Gregory M / Fries, Louis F / Smith, Gale / Kpamegan, Eloi / Lu, Hanxin / Guebre-Xabier, Mimi / Hickman, Somia P / Flyer, David

Vaccine

2015 Volume 33, Issue 47, Page(s) 6488–6492

Abstract: Background: Protection of newborns and young infants against RSV disease via maternal immunization mediated by transplacental transfer of antibodies is under evaluation in third-trimester pregnant women with the RSV recombinant F nanoparticle vaccine ( ... ...

Abstract	Background: Protection of newborns and young infants against RSV disease via maternal immunization mediated by transplacental transfer of antibodies is under evaluation in third-trimester pregnant women with the RSV recombinant F nanoparticle vaccine (RSV F vaccine). Since the hemichorial placental architecture in guinea pigs and humans is similar, the guinea pig model was employed to assess RSV F vaccine immunogenicity in pregnant sows and to compare RSV-specific maternal antibody levels in their pups. Methods: Thirty (30) presumptive pregnant guinea pigs were immunized on gestational day 25 and 46 with placebo (PBS), 30μg RSV F, or 30μg RSV F+400μg aluminum phosphate. Sera at delivery/birth (sows/pups) and 15 and 30 days post-partum (pups) were analyzed for the presence of anti-F IgG, palivizumab-competitive antibody (PCA) and RSV/A microneutralization (MN). Results: The rates of pregnancy and stillbirth were similar between controls and vaccinees. The vaccine induced high levels of anti-F IgG, PCA and MN in sows, with the highest levels observed in adjuvanted vaccinees. Placental transfer to pups was proportional to the maternal antibody levels, with concentration effects observed for all immune measures. Conclusions: The RSV F vaccine was safe and immunogenic in pregnant guinea pigs and supported robust transplacental antibody transfer to their pups. Relative concentration of antibodies in the pups was observed even in the presence of high levels of maternal antibody. Guinea pigs may be an important safety and immunogenicity model for preclinical assessment of candidate vaccines for maternal immunization.
MeSH term(s)	Adjuvants, Immunologic/administration & dosage ; Aluminum Compounds/administration & dosage ; Animals ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Female ; Guinea Pigs ; Immunity, Maternally-Acquired ; Immunoassay ; Immunoglobulin G/blood ; Maternal Exposure ; Phosphates/administration & dosage ; Placebos/administration & dosage ; Pregnancy ; Respiratory Syncytial Virus Vaccines/administration & dosage ; Respiratory Syncytial Virus Vaccines/adverse effects ; Respiratory Syncytial Virus Vaccines/immunology ; Viral Fusion Proteins/immunology
Chemical Substances	Adjuvants, Immunologic ; Aluminum Compounds ; Antibodies, Neutralizing ; Antibodies, Viral ; F protein, human respiratory syncytial virus ; Immunoglobulin G ; Phosphates ; Placebos ; Respiratory Syncytial Virus Vaccines ; Viral Fusion Proteins ; aluminum phosphate (F92V3S521O)
Language	English
Publishing date	2015-11-25
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2015.08.039
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Article ; Online: Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria.

Wu, Richard L / Idris, Azza H / Berkowitz, Nina M / Happe, Myra / Gaudinski, Martin R / Buettner, Christian / Strom, Larisa / Awan, Seemal F / Holman, LaSonji A / Mendoza, Floreliz / Gordon, Ingelise J / Hu, Zonghui / Campos Chagas, Andrezza / Wang, Lawrence T / Da Silva Pereira, Lais / Francica, Joseph R / Kisalu, Neville K / Flynn, Barbara J / Shi, Wei /

Kong, Wing-Pui / O'Connell, Sarah / Plummer, Sarah H / Beck, Allison / McDermott, Adrian / Narpala, Sandeep R / Serebryannyy, Leonid / Castro, Mike / Silva, Rosa / Imam, Marjaan / Pittman, Iris / Hickman, Somia P / McDougal, Andrew J / Lukoskie, Ashly E / Murphy, Jittawadee R / Gall, Jason G / Carlton, Kevin / Morgan, Patricia / Seo, Ellie / Stein, Judy A / Vazquez, Sandra / Telscher, Shinyi / Capparelli, Edmund V / Coates, Emily E / Mascola, John R / Ledgerwood, Julie E / Dropulic, Lesia K / Seder, Robert A

The New England journal of medicine

2022 Volume 387, Issue 5, Page(s) 397–407

Abstract: Background: New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed.: Methods: We conducted a phase 1 clinical trial to assess the safety and ... ...

Abstract	Background: New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed. Methods: We conducted a phase 1 clinical trial to assess the safety and pharmacokinetics of L9LS, a next-generation antimalarial monoclonal antibody, and its protective efficacy against controlled human malaria infection in healthy adults who had never had malaria or received a vaccine for malaria. The participants received L9LS either intravenously or subcutaneously at a dose of 1 mg, 5 mg, or 20 mg per kilogram of body weight. Within 2 to 6 weeks after the administration of L9LS, both the participants who received L9LS and the control participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying Results: No safety concerns were identified. L9LS had an estimated half-life of 56 days, and it had dose linearity, with the highest mean (±SD) maximum serum concentration (C Conclusions: In this small trial, L9LS administered intravenously or subcutaneously protected recipients against malaria after controlled infection, without evident safety concerns. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 614 ClinicalTrials.gov number, NCT05019729.).
MeSH term(s)	Administration, Cutaneous ; Administration, Intravenous ; Adult ; Animals ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/pharmacokinetics ; Child ; Child, Preschool ; Humans ; Malaria/prevention & control ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/prevention & control ; Parasitemia/parasitology ; Plasmodium falciparum
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2022-08-04
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2203067
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Article: A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age

August, Allison / D. Nigel Thomas / Dewal Jani / Eloi Kpamegan / Gregory M. Glenn / Hanxin Lu / Judy Wen / Louis F. Fries / Pedro A. Piedra / Somia P. Hickman

Vaccine. 2017 June 27, v. 35, no. 30

2017

Abstract: ... reduced by 52% overall (p=0.009 overall) over the Day 0 through 90 period.RSV F nanoparticle vaccine ...

Abstract	Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants. We are developing an RSV fusion (F) protein nanoparticle vaccine for immunization of third trimester pregnant women to passively protect infants through transfer of RSV-specific maternal antibodies. The present trial was performed to assess the immunogenicity and safety of several formulations of RSV F vaccine in 1-dose or 2-dose schedules.Placebo, or vaccine with 60μg or 120μg RSV F protein and 0.2, 0.4, or 0.8mg aluminum, were administered intramuscularly on Days 0 and 28 to healthy women 18–35years old. Immunogenicity was assessed from Days 0 through 91 based on anti-F IgG and palivizumab-competitive antibody (PCA) by ELISA, and RSV A and B neutralizing antibodies by microneutralization (MN) assay. Solicited adverse events were collected through Day 7 and unsolicited adverse events through Day 91.All formulations were well-tolerated, with no treatment-related serious adverse events. Anti-F IgG and PCA responses were correlated and increased after both doses, while MN increased significantly only after the first dose, then plateaued. The timeliest and most robust antibody responses followed one dose of 120μg RSV F protein and 0.4mg aluminum, but persistence through 91days was modestly (∼25%) superior following two doses of 60μg RSV F protein and 0.8mg aluminum. Western blot analysis showed RSV infections in active vaccinees were reduced by 52% overall (p=0.009 overall) over the Day 0 through 90 period.RSV F nanoparticle vaccine formulations were well tolerated and immunogenic. The optimal combination of convenience and rapid response for immunization in the third trimester occurred with 120μg RSV F and 0.4mg aluminum, which achieved peak immune responses in 14days and sufficient persistence through 91days to allow for passive transfer of IgG antibodies to the fetus. NCT01960686.
Keywords	aluminum ; enzyme-linked immunosorbent assay ; immune response ; immunization ; immunoglobulin G ; infants ; maternal immunity ; morbidity ; mortality ; nanoparticles ; neutralization ; neutralizing antibodies ; pregnant women ; vaccines ; viruses ; Western blotting
Language	English
Dates of publication	2017-0627
Size	p. 3749-3759.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2017.05.045
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Article: Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults.

Fries, Louis / Shinde, Vivek / Stoddard, Jeffrey J / Thomas, D Nigel / Kpamegan, Eloi / Lu, Hanxin / Smith, Gale / Hickman, Somia P / Piedra, Pedro / Glenn, Gregory M

Immunity & ageing : I & A

2017 Volume 14, Page(s) 8

Abstract: Background: A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, ... ...

Abstract	Background: A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, with or without aluminum phosphate adjuvant) administered concurrently with a licensed inactivated trivalent influenza vaccine (TIV) in older adult subjects were evaluated for safety and immunogenicity in this randomized, observer-blinded study. Results: A total of 220 healthy males and females ≥ 60 years of age, without symptomatic cardiopulmonary disease, were vaccinated concurrently with TIV and RSV F vaccine or placebo. All vaccine formulations produced an acceptable safety profile, with no vaccine-related serious adverse events or evidence of systemic toxicity. Vaccine-induced immune responses were rapid, rising as early as 7 days post-vaccination; and were comparable in all formulations in terms of magnitude, with maximal levels attained within 28 (unadjuvanted) or 56 (adjuvanted) days post-vaccination. Peak anti-F protein IgG antibody levels rose 3.6- to 5.6-fold, with an adjuvant effect observed at the 60 μg dose, and a dose-effect observed between the unadjuvanted 60 and 90 μg regimens. The anti-F response persisted through 12 months post-vaccination. Palivizumab-competitive antibodies were below quantifiable levels (<33 μg/mL) at day 0. The rise of antibodies with specificity for Site II peptide, and the palivizumab-competitive binding activity, denoting antibodies binding at, or in proximity to, antigenic Site II on the F protein, closely paralleled the anti-F response. However, a larger proportion of antibodies in adjuvanted vaccine recipients bound to the Site II peptide at high avidity. Day 0 neutralizing antibodies were high in all subjects and rose 1.3- to 1.7-fold in response to vaccination. Importantly, the RSV F vaccine co-administered with TIV did not impact the serum hemagglutination inhibition antibody responses to a standard-dose TIV, and TIV did not impact the immune response to the RSV F vaccine. Conclusions: RSV F protein nanoparticle vaccine induced increases in measures of functional immunity to RSV in older adults and demonstrated an acceptable safety profile. Adjuvanted formulations provided additional immunogenicity benefit as compared to increasing antigen dose alone. This trial was registered with ClinicalTrials.gov number NCT01709019.
Language	English
Publishing date	2017-04-12
Publishing country	England
Document type	Journal Article
ISSN	1742-4933
ISSN	1742-4933
DOI	10.1186/s12979-017-0090-7
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Article ; Online: A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age.

August, Allison / Glenn, Gregory M / Kpamegan, Eloi / Hickman, Somia P / Jani, Dewal / Lu, Hanxin / Thomas, D Nigel / Wen, Judy / Piedra, Pedro A / Fries, Louis F

Vaccine

2017 Volume 35, Issue 30, Page(s) 3749–3759

Abstract: ... showed RSV infections in active vaccinees were reduced by 52% overall (p=0.009 overall) over the Day 0 ...

Abstract	Objective: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants. We are developing an RSV fusion (F) protein nanoparticle vaccine for immunization of third trimester pregnant women to passively protect infants through transfer of RSV-specific maternal antibodies. The present trial was performed to assess the immunogenicity and safety of several formulations of RSV F vaccine in 1-dose or 2-dose schedules. Methods: Placebo, or vaccine with 60μg or 120μg RSV F protein and 0.2, 0.4, or 0.8mg aluminum, were administered intramuscularly on Days 0 and 28 to healthy women 18-35years old. Immunogenicity was assessed from Days 0 through 91 based on anti-F IgG and palivizumab-competitive antibody (PCA) by ELISA, and RSV A and B neutralizing antibodies by microneutralization (MN) assay. Solicited adverse events were collected through Day 7 and unsolicited adverse events through Day 91. Results: All formulations were well-tolerated, with no treatment-related serious adverse events. Anti-F IgG and PCA responses were correlated and increased after both doses, while MN increased significantly only after the first dose, then plateaued. The timeliest and most robust antibody responses followed one dose of 120μg RSV F protein and 0.4mg aluminum, but persistence through 91days was modestly (∼25%) superior following two doses of 60μg RSV F protein and 0.8mg aluminum. Western blot analysis showed RSV infections in active vaccinees were reduced by 52% overall (p=0.009 overall) over the Day 0 through 90 period. Conclusions: RSV F nanoparticle vaccine formulations were well tolerated and immunogenic. The optimal combination of convenience and rapid response for immunization in the third trimester occurred with 120μg RSV F and 0.4mg aluminum, which achieved peak immune responses in 14days and sufficient persistence through 91days to allow for passive transfer of IgG antibodies to the fetus. NCT01960686.
Language	English
Publishing date	2017-06-27
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2017.05.045
Database	MEDical Literature Analysis and Retrieval System OnLINE

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