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Article ; Online: "Direct and indirect impacts of the COVID-19 pandemic on operational conduct of pediatric vaccine clinical trials".

McArthur, Monica Anne / Bchir, Siham / Dubois, Estelle / Gan, Lucia / Gerchman, Eric / Gupta, Sandeep / Liabis, Olga / Perez, Lucia / Roche, Fabienne / Vasquez, Gustavo / Zambrano, Betzana / Gurunathan, Sanjay / Dhingra, Mandeep Singh

Human vaccines & immunotherapeutics

2023 Volume 19, Issue 3, Page(s) 2272535

Abstract: The coronavirus 2019 (COVID-19) pandemic, as well as the resulting public health measures, impacted many aspects of society. The conduct of important pediatric vaccine trials was among these. Analyzing data from six ongoing non-COVID-19 pediatric vaccine ...

Abstract	The coronavirus 2019 (COVID-19) pandemic, as well as the resulting public health measures, impacted many aspects of society. The conduct of important pediatric vaccine trials was among these. Analyzing data from six ongoing non-COVID-19 pediatric vaccine trials we aimed to assess the operational impact of the COVID-19 pandemic using descriptive analyses. We identified multiple operational disruptions in trial conduct. Additionally, we identified higher percentages of missed routine vaccinations than investigational vaccines throughout the observation period. Overall, the impact of the COVID-19 pandemic was most apparent early in the pandemic period while adaptations to the pandemic were developed; however, some disruptions persisted throughout the observation period. Pediatric vaccine clinical trials are critical to developing new and/or improved vaccines for the pediatric population. Continued evaluation of the impacts of COVID-19 on pediatric vaccine clinical trials is warranted.
MeSH term(s)	Child ; Humans ; Pandemics/prevention & control ; COVID-19/prevention & control ; Public Health ; Vaccination ; Vaccines
Chemical Substances	Vaccines
Language	English
Publishing date	2023-11-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2023.2272535
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Article ; Online: Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) in Meningococcal Vaccine-Naïve Participants across a Broad Age Range (2-55 Years) in Japan: a Phase III Randomized Study.

Matsuoka, Osamu / Ujiie, Mugen / Kikuchi, Hitoshi / Otake, Sachiko / Chansinghakul, Danaya / Inoue, Takahiro / Varghese, Kucku / Sirisuphmitr, Nuchra / Hashiguchi, Tomoyuki / Zambrano, Betzana / Nakama, Takahiro / Frago, Carina / Jordanov, Emilia / Dhingra, Mandeep Singh

Japanese journal of infectious diseases

2023 Volume 76, Issue 3, Page(s) 174–182

Abstract: MenACYW-TT is a quadrivalent meningococcal tetanus toxoid-conjugate vaccine designed to prevent invasive meningococcal disease. The primary objective of this study was to demonstrate non-inferiority of the vaccine seroresponse to a single dose of MenACYW- ...

Abstract	MenACYW-TT is a quadrivalent meningococcal tetanus toxoid-conjugate vaccine designed to prevent invasive meningococcal disease. The primary objective of this study was to demonstrate non-inferiority of the vaccine seroresponse to a single dose of MenACYW-TT compared with MCV4-DT, a licensed meningococcal quadrivalent diphtheria-conjugate vaccine. This Phase III double-blind, multicenter trial was conducted in meningococcal vaccine-naïve individuals aged 2-55 years in Japan (NCT04368429; jRCT2080225192). Participants were randomized 1:1 to receive either MenACYW-TT (n = 180) or MCV4-DT (n = 180). Functional antibodies against meningococcal serogroups A, C, W, and Y were measured using a serum bactericidal antibody assay with human complement (hSBA) at baseline (D0) and 30 days after vaccination (D30). Seroresponse was defined as a post-vaccination titer ≥1:16 in participants with a baseline titer <1:8; or a ≥4-fold increase in titer in participants with a baseline titer ≥1:8. Safety data were collected for 30 days. Non-inferiority of the seroresponse to MenACYW-TT vs. MCV4-DT was demonstrated on D30 for each serogroup tested (A: 85.6% vs. 65.4%; C: 96.6% vs. 62.6%; W: 87.4% vs. 49.2%; Y: 97.7% vs. 63.5%). MenACYW-TT was well tolerated with no safety concerns identified. A single dose of MenACYW-TT was well tolerated, with a non-inferior seroresponse compared with MCV4-DT. MenACYW-TT could thus be used as an alternative vaccine in meningococcal vaccine-naïve individuals.
MeSH term(s)	Humans ; Child, Preschool ; Child ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Tetanus Toxoid/adverse effects ; Meningococcal Vaccines ; Vaccines, Conjugate/adverse effects ; Japan ; Antibodies, Bacterial ; Meningococcal Infections/prevention & control ; Neisseria meningitidis ; Vaccines, Combined
Chemical Substances	Tetanus Toxoid ; Meningococcal Vaccines ; Vaccines, Conjugate ; Antibodies, Bacterial ; Vaccines, Combined
Language	English
Publishing date	2023-01-31
Publishing country	Japan
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Multicenter Study ; Journal Article
ZDB-ID	1478383-6
ISSN	1884-2836 ; 1344-6304
ISSN (online)	1884-2836
ISSN	1344-6304
DOI	10.7883/yoken.JJID.2022.272
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Article ; Online: Correction: Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study.

Zambrano, Betzana / Peterson, James / Deseda, Carmen / Julien, Katie / Spiegel, Craig A / Seyler, Clifford / Simon, Michael / Hoki, Robert / Anderson, Marc / Brabec, Brad / Áñez, Germán / Shi, Jiayuan / Pan, Judy / Hagenbach, Audrey / Von Barbier, Dalia / Varghese, Kucku / Jordanov, Emilia / Dhingra, Mandeep Singh

Pediatric research

2023 Volume 95, Issue 4, Page(s) 1159

Language	English
Publishing date	2023-10-04
Publishing country	United States
Document type	Published Erratum
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-023-02835-4
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Article ; Online: Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study.

Pediatric research

2023 Volume 94, Issue 3, Page(s) 1035–1043

Abstract: Background: The immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13-25-year olds who received MenACYW-TT or a ... ...

Abstract	Background: The immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13-25-year olds who received MenACYW-TT or a CRM-conjugate vaccine (MCV4-CRM) 3-6 years earlier. Methods: This phase IIIb open-label trial (NCT04084769) evaluated MenACYW-TT-primed participants, randomized to receive MenACYW-TT alone or with a MenB vaccine, and MCV4-CRM-primed participants who received MenACYW-TT alone. Functional antibodies against serogroups A, C, W and Y were measured using human complement serum bactericidal antibody assay (hSBA). The primary endpoint was vaccine seroresponse (post-vaccination titers ≥1:16 if pre-vaccination titers <1:8; or a ≥4-fold increase if pre-vaccination titers ≥1:8) 30 days post booster. Safety was evaluated throughout the study. Results: The persistence of the immune response following primary vaccination with MenACYW-TT was demonstrated. Seroresponse after MenACYW-TT booster was high regardless of priming vaccine (serogroup A: 94.8% vs 93.2%; C: 97.1% vs 98.9%; W: 97.7% vs 98.9%; and Y; 98.9% vs 100% for MenACWY-TT-primed and MCV4-CRM-primed groups, respectively). Co-administration with MenB vaccines did not affect MenACWY-TT immunogenicity. No vaccine-related serious adverse events were reported. Conclusions: MenACYW-TT booster induced robust immunogenicity against all serogroups, regardless of the primary vaccine received, and had an acceptable safety profile. Impact: A booster dose of MenACYW-TT induces robust immune responses in children and adolescents primed with MenACYW-TT or another MCV4 (MCV4-DT or MCV4-CRM), respectively. Here, we demonstrate that MenACYW-TT booster 3-6 years after primary vaccination induced robust immunogenicity against all serogroups, regardless of the priming vaccine (MenACWY-TT or MCV4-CRM), and was well tolerated. Persistence of the immune response following previous primary vaccination with MenACYW-TT was demonstrated. MenACYW-TT booster with MenB vaccine co-administration did not affect MenACWY-TT immunogenicity and was well tolerated. These findings will facilitate the provision of broader protection against IMD particularly in higher-risk groups such as adolescents.
MeSH term(s)	Child ; Humans ; Adult ; Adolescent ; Tetanus Toxoid ; Antibodies, Bacterial ; Vaccination ; Neisseria meningitidis ; Meningococcal Vaccines/adverse effects ; Vaccines, Conjugate
Chemical Substances	Tetanus Toxoid ; Antibodies, Bacterial ; Meningococcal Vaccines ; Vaccines, Conjugate
Language	English
Publishing date	2023-03-10
Publishing country	United States
Document type	Clinical Trial, Phase III ; Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-023-02478-5
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Article ; Online: Safety and immunogenicity of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine in adults and children in Vellore, South India.

Raghava Mohan, Venkata / Raj, Santosh / Dhingra, Mandeep Singh / Aloysia D'Cor, Naveena / Singh, Ajit Pal / Saluja, Tarun / Kim, Deok Ryun / Midde, Venkat Jayanth / Kim, Yanghee / Vemula, Sridhar / Narla, Santhosh Kumar / Sah, Binod / Ali, Mohammad

PloS one

2019 Volume 14, Issue 6, Page(s) e0218033

Abstract: This open-label study assessed the safety and immunogenicity of two doses (14 days apart) of an indigenously manufactured, killed, bivalent (Vibrio cholerae O1 and O139), whole-cell oral cholera vaccine (SHANCHOL; Shantha Biotechnics) in healthy adults ( ... ...

Abstract	This open-label study assessed the safety and immunogenicity of two doses (14 days apart) of an indigenously manufactured, killed, bivalent (Vibrio cholerae O1 and O139), whole-cell oral cholera vaccine (SHANCHOL; Shantha Biotechnics) in healthy adults (n = 100) and children (n = 100) in a cholera endemic area (Vellore, South India) to fulfill post-licensure regulatory requirements and post-World Health Organization (WHO) prequalification commitments. Safety and reactogenicity were assessed, and seroconversion rates (i.e. proportion of participants with a ≥ 4-fold rise from baseline in serum vibriocidal antibody titers against V. cholerae O1 Inaba, O1 Ogawa and O139, respectively) were determined 14 days after each vaccine dose. No serious adverse events were reported during the study. Commonly reported solicited adverse events were headache and general ill feeling. Seroconversion rates after the first and second dose in adults were 67.7% and 55.2%, respectively, against O1 Inaba; 47.9% and 45.8% against O1 Ogawa; and 19.8% and 20.8% against O139. In children, seroconversion rates after the first and second dose were 80.2% and 68.8%, respectively, against O1 Inaba; 72.9% and 67.7% against O1 Ogawa; and 26.0% and 18.8% against O139. The geometric mean titers against O1 Inaba, O1 Ogawa, and O139 in both adults and children were significantly higher after each vaccine dose compared to baseline titers (P < 0.001; for both age groups after each dose versus baseline). The seroconversion rates for O1 Inaba, O1 Ogawa, and O139 in both age groups were similar to those in previous studies with the vaccine. In conclusion, the killed, bivalent, whole-cell oral cholera vaccine has a good safety and reactogenicity profile, and is immunogenic in healthy adults and children. Trial Registration: ClinicalTrials.gov NCT00760825; CTRI/2012/01/002354.
MeSH term(s)	Administration, Oral ; Adolescent ; Adult ; Antibody Formation ; Child ; Cholera/immunology ; Cholera/microbiology ; Cholera/pathology ; Cholera/prevention & control ; Cholera Vaccines/administration & dosage ; Cholera Vaccines/adverse effects ; Cholera Vaccines/immunology ; Female ; Headache/epidemiology ; Headache/immunology ; Headache/pathology ; Humans ; Immunogenicity, Vaccine ; India/epidemiology ; Male ; Vaccination/methods ; Vaccines, Inactivated/administration & dosage ; Vaccines, Inactivated/adverse effects ; Vaccines, Inactivated/immunology ; Vibrio cholerae O1/immunology ; Vibrio cholerae O1/pathogenicity ; Vibrio cholerae O139/immunology ; Vibrio cholerae O139/pathogenicity ; Young Adult
Chemical Substances	Cholera Vaccines ; Vaccines, Inactivated
Language	English
Publishing date	2019-06-18
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0218033
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Article ; Online: Human and bovine rotavirus strain antigens for evaluation of immunogenicity in a randomized, double-blind, placebo-controlled trial of a single dose live attenuated tetravalent, bovine-human-reassortant, oral rotavirus vaccine in Indian adults.

Paul, Anu / Babji, Sudhir / Sowmyanarayanan, T V / Dhingra, Mandeep Singh / Ramani, Sasirekha / Kattula, Deepthi / Kang, Gagandeep

Vaccine

2014 Volume 32, Issue 25, Page(s) 3094–3100

Abstract: A single dose of live attenuated tetravalent (G1-G4) bovine human reassortant rotavirus vaccine (BRV-TV) was administered to healthy Indian adult volunteers, who were assessed for safety and immunogenicity of the vaccine with 3:1 randomization to vaccine ...

Abstract	A single dose of live attenuated tetravalent (G1-G4) bovine human reassortant rotavirus vaccine (BRV-TV) was administered to healthy Indian adult volunteers, who were assessed for safety and immunogenicity of the vaccine with 3:1 randomization to vaccine or placebo. All 20 adult male volunteers in the study had rotavirus specific serum IgA at baseline. There were no side effects or adverse events reported. Administration of BRV-TV was not associated with fever, diarrhea, or altered liver transaminases. Rotavirus IgA seroconversion post single dose administration was 27%. This study shows that BRV-TV is non-reactogenic, safe and immunogenic in adults. The IgA units estimated for the same sample using human G1P[8] rotavirus strain as the antigen were consistently higher than with the bovine G6P[5] WC3 strain and the human G2P[4] DS-1 strain antigen. The use of different human and bovine rotavirus strains as antigens in a quantitative rotavirus specific serum IgA assay resulted in different estimations of IgA antibody in the same sample.
MeSH term(s)	Adult ; Antibodies, Viral/blood ; Double-Blind Method ; Humans ; Immunoglobulin A/blood ; Male ; Middle Aged ; Rotavirus/classification ; Rotavirus Infections/prevention & control ; Rotavirus Vaccines/immunology ; Rotavirus Vaccines/therapeutic use ; Vaccines, Attenuated/immunology ; Vaccines, Attenuated/therapeutic use ; Young Adult
Chemical Substances	Antibodies, Viral ; Immunoglobulin A ; Rotavirus Vaccines ; Vaccines, Attenuated
Language	English
Publishing date	2014-05-23
Publishing country	Netherlands
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2014.03.013
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Article ; Online: Safety and immunogenicity of the killed bivalent (O1 and O139) whole-cell cholera vaccine in the Philippines.

Capeding, Maria Rosario Z / Gonzales, Maria Liza Antoinette M / Dhingra, Mandeep Singh / D'Cor, Naveena Aloysia / Midde, Venkat Jayanth / Patnaik, Badri Narayan / Thollot, Yaël / Desauziers, Eric

Human vaccines & immunotherapeutics

2017 Volume 13, Issue 10, Page(s) 2232–2239

Abstract: The killed bivalent (O1 and O139) whole cell oral cholera vaccine (OCV) (Shanchol™) was first licensed in India in 2009 and World Health Organization pre-qualified in 2011. We assessed the safety and immunogenicity of this OCV in the Philippines. This ... ...

Abstract	The killed bivalent (O1 and O139) whole cell oral cholera vaccine (OCV) (Shanchol™) was first licensed in India in 2009 and World Health Organization pre-qualified in 2011. We assessed the safety and immunogenicity of this OCV in the Philippines. This was a phase IV, single-arm, descriptive, open-label study. We recruited 336 participants from 2 centers: 112 participants in each age group (1-4, 5-14 and ≥ 15 years). Participants received 2 OCV doses 14 d apart. Safety was monitored throughout the trial. Blood samples were collected at baseline (pre-vaccination) and 14 d after each dose. Serum vibriocidal antibody titers to V. cholerae O1 (El Tor Inaba and El Tor Ogawa) and O139 strains were assessed, with seroconversion defined as ≥ 4-fold increase from baseline in titers. No immediate unsolicited systemic adverse events/reactions were observed. Unsolicited systemic adverse events were mostly grade 1 intensity. One serious adverse event occurred after the first dose, but was unrelated to vaccination. High seroconversion rates (range 69-92%) were achieved against the O1 serotypes with a trend toward higher rates in the 1-4 y (86-92%) and 5-14 y (86-88%) age groups than the ≥ 15 y age group (69-83%). Lower seroconversion rates were achieved against the O139 serotype (35-70%), particularly in those aged ≥ 15 y (35-42%). The 2-dose regimen of the killed bivalent whole cell OCV was well-tolerated in this study conducted in the Philippines, a cholera-endemic country. Robust immune responses were observed even after a single-dose.
MeSH term(s)	Administration, Oral ; Adolescent ; Antibodies, Bacterial/blood ; Child ; Child, Preschool ; Cholera/epidemiology ; Cholera/prevention & control ; Cholera Vaccines/administration & dosage ; Cholera Vaccines/adverse effects ; Cholera Vaccines/immunology ; Female ; Humans ; Immunogenicity, Vaccine ; Infant ; Male ; Philippines/epidemiology ; Seroconversion ; Vaccination ; Vaccines, Inactivated/administration & dosage ; Vaccines, Inactivated/adverse effects ; Vaccines, Inactivated/immunology ; Vibrio cholerae O1/immunology
Chemical Substances	Antibodies, Bacterial ; Cholera Vaccines ; Vaccines, Inactivated
Language	English
Publishing date	2017-08-29
Publishing country	United States
Document type	Clinical Trial, Phase IV ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2017.1342908
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Article ; Online: Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone.

Kanungo, Suman / Desai, Sachin N / Nandy, Ranjan Kumar / Bhattacharya, Mihir Kumar / Kim, Deok Ryun / Sinha, Anuradha / Mahapatra, Tanmay / Yang, Jae Seung / Lopez, Anna Lena / Manna, Byomkesh / Bannerjee, Barnali / Ali, Mohammad / Dhingra, Mandeep Singh / Chandra, Ananga Mohan / Clemens, John D / Sur, Dipika / Wierzba, Thomas F

PLoS neglected tropical diseases

2015 Volume 9, Issue 3, Page(s) e0003574

Abstract: Background: A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata, India, when given in a two dose schedule, two weeks apart. A randomized controlled trial ... ...

Abstract	Background: A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata, India, when given in a two dose schedule, two weeks apart. A randomized controlled trial revealed that the immune response was not significantly increased following the second dose compared to that after the first dose. We aimed to evaluate the impact of an extended four week dosing schedule on vibriocidal response. Methodology/principal findings: In this double blind randomized controlled non-inferiority trial, 356 Indian, non-pregnant residents aged 1 year or older were randomized to receive two doses of oral cholera vaccine at 14 and 28 day intervals. We compared vibriocidal immune responses between these schedules. Among adults, no significant differences were noted when comparing the rates of seroconversion for V. cholerae O1 Inaba following two dose regimens administered at a 14 day interval (55%) vs the 28 day interval (58%). Similarly, no differences in seroconversion were demonstrated in children comparing the 14 (80%) and 28 day intervals (77%). Following 14 and 28 day dosing intervals, vibriocidal response rates against V. cholerae O1 Ogawa were 45% and 49% in adults and 73% and 72% in children respectively. Responses were lower for V. cholerae O139, but similar between dosing schedules for adults (20%, 20%) and children (28%, 20%). Conclusions/significance: Comparable immune responses and safety profiles between the two dosing schedules support the option for increased flexibility of current OCV dosing. Further operational research using a longer dosing regimen will provide answers to improve implementation and delivery of cholera vaccination in endemic and epidemic outbreak scenarios.
MeSH term(s)	Administration, Oral ; Adolescent ; Adult ; Antibodies, Bacterial/blood ; Child ; Child, Preschool ; Cholera/epidemiology ; Cholera Vaccines/adverse effects ; Cholera Vaccines/immunology ; Double-Blind Method ; Epidemics ; Female ; Humans ; India/epidemiology ; Infant ; Male ; Vaccination ; Vibrio cholerae/immunology
Chemical Substances	Antibodies, Bacterial ; Cholera Vaccines
Language	English
Publishing date	2015-03-12
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2429704-5
ISSN	1935-2735 ; 1935-2735
ISSN (online)	1935-2735
ISSN	1935-2735
DOI	10.1371/journal.pntd.0003574
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Article: Salmonella typhi septic arthritis of hip--a case report.

Agnihotri, Nalini / Dhingra, Mandeep Singh / Gautam, Vikas / Gupta, Varsha / Kaushal, Rishi / Mehta, Deepak

Japanese journal of infectious diseases

2005 Volume 58, Issue 1, Page(s) 29–30

Abstract: A case of rarely encountered Salmonella Typhi septic arthritis of the hip in a child with no preexisting disease is reported. Salmonella etiology was not suspected in this case, and the diagnosis was made only after bacterial isolation. Arthrotomy was ... ...

Abstract	A case of rarely encountered Salmonella Typhi septic arthritis of the hip in a child with no preexisting disease is reported. Salmonella etiology was not suspected in this case, and the diagnosis was made only after bacterial isolation. Arthrotomy was done as an initial mode of management, followed by intravenous ciprofloxacin therapy to which the child responded favorably.
MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Arthritis, Infectious/drug therapy ; Arthritis, Infectious/microbiology ; Arthritis, Infectious/surgery ; Child ; Ciprofloxacin/therapeutic use ; Female ; Hip/microbiology ; Humans ; Salmonella Infections/drug therapy ; Salmonella Infections/microbiology ; Salmonella typhi/isolation & purification
Chemical Substances	Anti-Bacterial Agents ; Ciprofloxacin (5E8K9I0O4U)
Language	English
Publishing date	2005-02
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	1478383-6
ISSN	1884-2836 ; 1344-6304
ISSN (online)	1884-2836
ISSN	1344-6304
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Article ; Online: Live attenuated tetravalent (G1-G4) bovine-human reassortant rotavirus vaccine (BRV-TV): Randomized, controlled phase III study in Indian infants.

Vaccine

2017 Volume 35, Issue 28, Page(s) 3575–3581

Abstract: Background: Rotavirus remains the leading cause of diarrhoea among children <5years. We assessed immunogenic non-inferiority of a tetravalent bovine-human reassortant rotavirus vaccine (BRV-TV) over the licensed human-bovine pentavalent rotavirus ... ...

Abstract	Background: Rotavirus remains the leading cause of diarrhoea among children <5years. We assessed immunogenic non-inferiority of a tetravalent bovine-human reassortant rotavirus vaccine (BRV-TV) over the licensed human-bovine pentavalent rotavirus vaccine RV5. Methods: Phase III single-blind study (parents blinded) in healthy infants randomized (1:1) to receive three doses of BRV-TV or RV5 at 6-8, 10-12, and 14-16weeks of age. All concomitantly received a licensed diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine (DTwP-HepB-Hib) and oral polio vaccine (OPV). Immunogenic non-inferiority was evaluated in terms of the inter-group difference in anti-rotavirus serum IgA seroresponse (primary endpoint), and seroprotection/seroresponse rates to DTwP-HepB-Hib and OPV vaccines. Seroresponse was defined as a ≥4-fold increase in titers from baseline to D28 post-dose 3. Non-inferiority was declared if the difference between groups (based on the lower limit of the 95% confidence interval [CI]) was above -10%. Each subject was evaluated for solicited adverse events 7days and unsolicited & serious adverse events 28days following each dose of vaccination. Results: Of 1195 infants screened, 1182 were randomized (590 to BRV-TV; 592 to RV5). Non-inferiority for rotavirus serum IgA seroresponse was not established: BRV-TV, 47.1% (95%CI: 42.8; 51.5) versus RV5, 61.2% (95%CI: 56.8; 65.5); difference between groups, -14.08% (95%CI: -20.4; -7.98). Serum IgA geometric mean concentrations at D28 post-dose 3 were 28.4 and 50.1U/ml in BRV-TV and RV5 groups, respectively. For all DTwP-HepB-Hib and OPV antigens, seroprotection/seroresponse was elicited in both groups and the -10% non-inferiority criterion between groups was met. There were 16 serious adverse events, 10 in BRV-TV group and 6 in RV5 group; none were classified as vaccine related. Both groups had similar vaccine safety profiles. Conclusion: BRV-TV was immunogenic but did not meet immunogenic non-inferiority criteria to RV5 when administered concomitantly with routine pediatric antigens in infants.
Language	English
Publishing date	2017-06-16
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.2017.05.019
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