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  1. Article ; Online: The impact of community engagement as a public health intervention to support the mental well-being of single mothers and children living under housing insecure conditions - a rapid literature review.

    Joseph, Natasha / Burn, Anne-Marie / Anderson, Joanna

    BMC public health

    2023  Volume 23, Issue 1, Page(s) 1866

    Abstract: Background: In the UK, the population of homelessness and housing insecurity is increasing among families headed by mothers. The unique stressors of housing insecurity and living in accommodations ill-suited to long-term dwellings increase mental ... ...

    Abstract Background: In the UK, the population of homelessness and housing insecurity is increasing among families headed by mothers. The unique stressors of housing insecurity and living in accommodations ill-suited to long-term dwellings increase mental distress for mothers and children. Community engagement interventions present a public health opportunity to alleviate adverse outcomes for vulnerable families.
    Aim: To synthesise and evaluate evidence of the impact of community engagement interventions in supporting the mental well-being of mothers and children living under housing insecure conditions. To synthesise the components of community engagement interventions as a public health intervention in alleviating mental well-being and non-health outcomes of mothers and children living under housing insecurity.
    Methods: A systematic search of five online bibliographic databases (MEDLINE, EMBASE, PsychINFO, Global Health and Child Development & Adolescent Studies) and grey literature (Carrot2) was conducted in May 2022. Primary studies with community engagement components and housing-insecure single-mother families were included. Intervention data was extracted using the TIDieR checklist and a community engagement keywording tool. The studies' quality was critically appraised using the MetaQAT framework.
    Results: Ten studies meeting inclusion criteria were identified, across two countries (USA & UK). Data from the studies reported positive significant effects for health and personal maternal outcomes in addition to higher positive effects for child health outcomes (e.g., decrease in depression symptoms). Interventions targeting social support and self-efficacy demonstrated potential to improve maternal and child outcomes via the maternal-child relationship. Community engagement at the design, delivery and evaluation intervention stages increased the level of community engagement, however there were tentative links to directly improving mental well-being outcomes.
    Conclusion: There is evidence to suggest that community engagement may be applied as an effective intervention in supporting the mental well-being of mothers and children living under housing insecurity. Proposed intervention effectiveness may be achieved via psychosocial pathways such as improved maternal self-efficacy and social support. However, more embedded long-term process evaluations of these interventions are needed to establish maintenance of these observed benefits and to understand to what extent the findings apply to the UK context.
    MeSH term(s) Adolescent ; Female ; Humans ; Housing ; Mental Disorders ; Mental Health ; Mother-Child Relations ; Public Health
    Language English
    Publishing date 2023-09-26
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2041338-5
    ISSN 1471-2458 ; 1471-2458
    ISSN (online) 1471-2458
    ISSN 1471-2458
    DOI 10.1186/s12889-023-16668-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial.

    Madhi, Shabir A / Moodley, Dhayendre / Hanley, Sherika / Archary, Moherndran / Hoosain, Zaheer / Lalloo, Umesh / Louw, Cheryl / Fairlie, Lee / Fouche, Leon Frederik / Masilela, Mduduzi S L / Singh, Nishanta / Grobbelaar, Coert / Ahmed, Khatija / Benadé, Gabriella / Bhikha, Sutika / Bhorat, As'ad Ebrahim / Bhorat, Qasim / Joseph, Natasha / Dheda, Keertan /
    Esmail, Aliasgar / Foulkes, Sharne / Goga, Ameena / Oommen Jose, Aylin / Kruger, Gertruida / Kalonji, Dishiki J / Lalloo, Natasha / Lombaard, Johan J / Lombard Koen, Anthonet / Kany Luabeya, Angelique / Mngqibisa, Rosie / Petrick, Friedrich G / Pitsi, Annah / Tameris, Michele / Thombrayil, Asha / Vollgraaff, Pieter-Louis / Cloney-Clark, Shane / Zhu, Mingzhu / Bennett, Chijioke / Albert, Gary / Faust, Emmanuel / Plested, Joyce S / Fries, Lou / Robertson, Andreana / Neal, Susan / Cho, Iksung / Glenn, Greg M / Shinde, Vivek

    The lancet. HIV

    2023  Volume 9, Issue 5, Page(s) e309–e322

    Abstract: Background: There is a paucity of data on COVID-19 vaccines in people living with HIV-1, who could be at increased risk of severe illness and death from COVID-19. We evaluated the safety and immunogenicity of a Matrix-M adjuvanted recombinant spike ... ...

    Abstract Background: There is a paucity of data on COVID-19 vaccines in people living with HIV-1, who could be at increased risk of severe illness and death from COVID-19. We evaluated the safety and immunogenicity of a Matrix-M adjuvanted recombinant spike protein nanoparticle COVID-19 vaccine (NVX-CoV2373; Novavax) in HIV-negative people and people living with HIV-1.
    Methods: In this randomised, observer-blinded, multicentre, placebo-controlled phase 2A/B trial in South Africa, participants aged 18-84 years, with and without underlying HIV-1, were enrolled from 16 sites and randomly assigned (1:1) to receive two intramuscular injections of NVX-CoV2373 or placebo, 21 days apart. People living with HIV-1 were on stable antiretroviral therapy and had an HIV-1 viral load of less than 1000 copies per mL. Vaccine dosage was 5 μg SARS-CoV-2 recombinant spike protein with 50 μg Matrix-M adjuvant, whereas 0·9% saline was used as placebo injection (volume 0·5 mL each). All study staff and participants remained masked to study group assignment. We previously reported an interim analysis on the efficacy and safety of the NVX-CoV2373 vaccine (coprimary endpoints). In this Article, we present an expanded safety analysis for the full cohort of participants and report on the secondary objective of vaccine immunogenicity in the full cohort of people living with HIV-1 and in HIV-negative individuals overall and stratified by baseline SARS-CoV-2 serostatus. This trial is registered with ClinicalTrials.gov, NCT04533399, and the Pan-African Clinical Trials Registry, PACTR202009726132275.
    Findings: Participants were enrolled between Aug 17 and Nov 25, 2020. The safety analysis set included 4164 HIV-negative participants (2089 in the intervention group and 2075 in the placebo group) and 244 people living with HIV-1 (122 in the intervention group and 122 in the placebo group). 1422 (34·1%) of 4164 HIV-negative people and 83 (34·0%) of 244 people living with HIV-1 were categorised as baseline SARS-CoV-2-positive (ie, anti-spike IgG reactive at enrolment or had a reactive SARS-CoV-2 nucleic acid amplification test by 14 days after the second study vaccination). In the NVX-CoV2373 group, solicited local and systemic adverse events were more common in HIV-negative participants (427 [30·6%] local and 401 [28·7%] systemic) than in people living with HIV-1 (20 [25·3%] local and 20 [25·3%] systemic) among those who were baseline SARS-CoV-2-seronegative (naive). Of the serious adverse events that occurred among HIV-negative people (of whom, two [0·1%] were baseline SARS-CoV-2-negative and four [0·6%] were baseline SARS-CoV-2-positive) and people living with HIV-1 (for whom there were no serious adverse events) in the NVX-CoV2373 group, none were assessed as related to the vaccine. Among participants who were baseline SARS-CoV-2-negative in the NVX-CoV2373 group, the anti-spike IgG geometric mean titres (GMTs) and seroconversion rates (SCRs) were lower in people living with HIV-1 (n=62) than in HIV-negative people (n=1234) following the first vaccination (GMT: 508·6 vs 1195·3 ELISA units [EU]/mL; SCR: 51·6% vs 81·3%); and similarly so 14 days after the second vaccination for GMTs (14 420·5 vs 31 631·8 EU/mL), whereas the SCR was similar at this point (100·0% vs 99·3%). In the NVX-CoV2373 group, anti-spike IgG GMTs 14 days after the second vaccination were substantially higher in those who were baseline SARS-CoV-2-positive than in those who were baseline SARS-CoV-2-seronegative for HIV-negative participants (100 666·1 vs 31 631·8 EU/mL) and for people living with HIV-1 (98 399·5 vs 14 420·5 EU/mL). This was also the case for angiotensin-converting enzyme 2 receptor-binding antibody and neutralising antibody titres.
    Interpretation: The safety of the NVX-CoV2373 vaccine in people living with HIV-1 was similar to that in HIV-negative participants. However, people living with HIV-1 not previously exposed to SARS-CoV-2 had attenuated humoral immune responses to NVX-CoV2373 compared with their HIV-negative vaccine counterparts, but not so if they were baseline SARS-CoV-2-positive.
    Funding: Novavax and the Bill & Melinda Gates Foundation; investigational vaccine manufacturing support was provided by the Coalition for Epidemic Preparedness Innovations.
    MeSH term(s) Adjuvants, Immunologic ; Antibodies, Viral ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; HIV Infections ; HIV Seropositivity ; HIV-1 ; Humans ; Immunoglobulin G ; Nanoparticles ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus ; Viral Vaccines
    Chemical Substances Adjuvants, Immunologic ; Antibodies, Viral ; COVID-19 Vaccines ; Immunoglobulin G ; Spike Glycoprotein, Coronavirus ; Viral Vaccines ; spike protein, SARS-CoV-2 ; NVX-CoV2373 adjuvated lipid nanoparticle (2SCD8Q63PF)
    Language English
    Publishing date 2023-11-30
    Publishing country Netherlands
    Document type Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ISSN 2352-3018
    ISSN (online) 2352-3018
    DOI 10.1016/S2352-3018(22)00041-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Novavax NVX-COV2373 triggers potent neutralization of Omicron sub-lineages

    Bhiman, Jinal Nomathemba / Richardson, Simone Irene / Lambson, Bronwen E / Kgagudi, Prudence / Mzindle, Nonkululeko / Kaldine, Haajira / Crowther, Carol / Gray, Glenda / Bekker, Linda-Gail / Koen, Anthonet / Fairlie, Lee / Fouche, Leon / Bhorat, Qasim / Dheda, Keertan / Tameris, Michele / Masilela, Mduduzi Sandile Lawrance / Hoosain, Zaheer / Singh, Nishanta / Hanley, Sherika /
    Archary, Moherndran / Louw, Cheryl / Grobbelaar, Coert / Lalloo, Umesh / Joseph, Natasha / Kruger, Gertruida / Shinde, Vivek / Bennett, Chijioke / Glenn, Gregory / Madhi, Shabir / Moore, Penny Linda

    bioRxiv

    Abstract: The SARS-CoV-2 Omicron (B.1.1.529) Variant of Concern (VOC) and its sub-lineages (including BA.2, BA.4/5, BA.2.12.1) contain spike mutations that confer high level resistance to neutralizing antibodies. The NVX-CoV2373 vaccine, a protein nanoparticle ... ...

    Abstract The SARS-CoV-2 Omicron (B.1.1.529) Variant of Concern (VOC) and its sub-lineages (including BA.2, BA.4/5, BA.2.12.1) contain spike mutations that confer high level resistance to neutralizing antibodies. The NVX-CoV2373 vaccine, a protein nanoparticle vaccine, has value in countries with constrained cold-chain requirements. Here we report neutralizing titers following two or three doses of NVX-CoV2373. We show that after two doses, Omicron sub-lineages BA.1 and BA.4 were resistant to neutralization by 72% (21/29) and 59% (17/29) of samples. However, after a third dose of NVX-CoV2373, we observed high titers against Omicron BA.1 (GMT: 1,197) and BA.4 (GMT: 582), with responses similar in magnitude to those triggered by three doses of an mRNA vaccine. These data are of particular relevance as BA.4 is emerging to become the dominant strain in many locations, and highlight the potential utility of the NVX-CoV2373 vaccine as a booster in resource-limited environments.
    Keywords covid19
    Language English
    Publishing date 2022-07-17
    Publisher Cold Spring Harbor Laboratory
    Document type Article ; Online
    DOI 10.1101/2022.07.14.500148
    Database COVID19

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