scholarly journals Participants’ characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jill Hanass-Hancock ◽  
Bradley Carpenter ◽  
Tarylee Reddy ◽  
Ayanda Nzuza ◽  
Zakir Gaffoor ◽  
...  
Keyword(s):  
South Africa ◽  
Monoclonal Antibody ◽  
Immune Response ◽  
Clinical Trials ◽  
Hiv Risk ◽  
Hiv Vaccine ◽  
Safety And Efficacy ◽  
Kwazulu Natal ◽  
Clade C ◽  
Motivation To Participate

Abstract Background HIV is one of the greatest public health challenges in South Africa. Potential HIV vaccines and antibodies are thought to be cost-effective biomedical HIV prevention methods and are currently under investigation in phase I, II, and III trials. Consequently, current and future clinical trials need to ensure sufficient recruitment and retention. To achieve this goal, clinical trial staff need to understand the socio-demographic and behavioural characteristics of people volunteering to screen for these trials and their reasons for volunteering. Methods We conducted a secondary analysis of participant screening data across five vaccine and monoclonal antibody trials at four sites in KwaZulu-Natal, South Africa. Our study reviewed the demographic, behavioural, motivational, and health-related data from the case report forms and screening questionnaires. Descriptive statistics, chi-squared, and one-way ANOVA tests were used to analyse participants’ characteristics and motivation to participate in HIV vaccine and monoclonal antibody trials. Analyses were conducted using R version 3.5.2. Results Screening data from 1934 participants, including 79.2% of women, were obtained across all five trials (1034 enrolled, 900 screened out/declined). Screened participants predominately self-identified as black, heterosexual, cisgender women or men, many with lower educational backgrounds (43.9% did not complete secondary/high school), and several self-reported HIV-risk behaviours among themselves and their partners. 10.8% of the screened participants were living with HIV. Avoiding HIV risk was the main motivation to participate in clinical trials, followed by altruistic reasons such as a desire to help the community or helping to find a vaccine. Discussion The current recruitment approach of these trials attracts heterosexual participants who seek to reduce HIV risk and support their community. Hence, the data suggest the need for and potential acceptance of continued ongoing HIV prevention efforts. Current trials attract participants with lower educational levels, which may be driven by the site locations, current community mobilisation strategies and research site opening hours. The sites could consider more flexible working hours to accommodate working participants and find ways to connect participants to educational support and opportunities to upgrade education levels for the current clientele. Trial registration HVTN 100: A Safety and Immune Response Study of 2 Experimental HIV Vaccines, NCT02404311. Registered on March 17, 2015. HVTN 111: Safety and Immune Response to a Clade C DNA HIV Vaccine, NCT02997969. Registered on December 16, 2016. HVTN 108: Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults, NCT02915016. Registered on September 22, 2016. HVTN 702: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa, NCT02968849. Registered on November 1, 2016. HVTN 703/HPTN 081: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women, NCT02568215. Registered on October 1, 2015.

scholarly journals Coital frequency and condom use in age-disparate partnerships involving women aged 15 to 24: evidence from a cross-sectional study in KwaZulu-Natal, South Africa

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024362 ◽  
Author(s):  
Gavin George ◽  
Brendan Maughan-Brown ◽  
Sean Beckett ◽  
Meredith Evans ◽  
Cherie Cawood ◽  
...  
Keyword(s):  
South Africa ◽  
Condom Use ◽  
Young Women ◽  
Hiv Risk ◽  
Cross Sectional Study ◽  
Secondary Outcome ◽  
Sectional Study ◽  
Coital Frequency ◽  
Cross Sectional ◽  
Kwazulu Natal

ObjectiveThis study examines the role of age-disparate partnerships on young women’s HIV risk by investigating coital frequency and condom use within age-disparate partnerships involving women aged 15 to 24.DesignA community-based, cross-sectional study was conducted.SettingParticipants were randomly selected using a two-stage random sampling method in uMgungundlovu district, KwaZulu-Natal, South Africa, between June 2014 and June 2015.ParticipantsA total of 1306 15–24-year-old women in an ongoing heterosexual partnership were included in the analysis. Participants had to be a resident in the area for 12 months, and able to provide informed consent and speak one of the local languages (Zulu or English).Primary and secondary outcome measuresSexual frequency was assessed by asking participants how many times they had sex with each partner in the past 12 months. The degree of condomless sex within partnerships was assessed in the survey by asking participants how often they used a condom with their partners.ResultsAge-disparate partnerships were associated with a higher order category (once, 2–5, 6–10, 11–20, >20) of coital frequency (adjusted OR (aOR) 1.32, p<0.05, 95% CI 1.02 to 1.71) and with sex on more than 10 occasions (aOR 1.48, p<0.01, 95% CI 1.12 to 1.96) compared with age-similar partnerships. Age-disparate partnerships were also more likely to involve sex on more than 10 occasions with inconsistent condom use (aOR 1.43, p<0.05, 95% CI 1.04 to 1.96) in the previous 12 months.ConclusionThe finding that increased sexual activity is positively associated with age-disparate partnerships adds to the evidence that age-disparate partnerships pose greater HIV risk for young women. Our study results indicate that interventions to reduce risky sexual behaviour within age-disparate partnerships remain relevant to reducing the high HIV incidence rates among adolescent girls and young women.

scholarly journals Immune correlates of the Thai RV144 HIV vaccine regimen in South Africa

2019 ◽  
Vol 11 (510) ◽  
pp. eaax1880 ◽  
Author(s):  
Glenda E. Gray ◽  
Ying Huang ◽  
Nicole Grunenberg ◽  
Fatima Laher ◽  
Surita Roux ◽  
...  
Keyword(s):  
South Africa ◽  
T Cell ◽  
Immune Responses ◽  
Hiv Vaccine ◽  
Antibody Responses ◽  
Vaccine Regimen ◽  
Humoral Immune ◽  
Immune Correlates ◽  
Clade C ◽  
Hiv 1

One of the most successful HIV vaccines to date, the RV144 vaccine tested in Thailand, demonstrated correlates of protection including cross-clade V1V2 immunoglobulin G (IgG) breadth, Env-specific CD4+ T cell polyfunctionality, and antibody-dependent cellular cytotoxicity (ADCC) in vaccinees with low IgA binding. The HIV Vaccine Trials Network (HVTN) 097 trial evaluated this vaccine regimen in South Africa, where clade C HIV-1 predominates. We compared cellular and humoral responses at peak and durability immunogenicity time points in HVTN 097 and RV144 vaccinee samples, and evaluated vaccine-matched and cross-clade immune responses. At peak immunogenicity, HVTN 097 vaccinees exhibited significantly higher cellular and humoral immune responses than RV144 vaccinees. CD4+ T cell responses were more frequent in HVTN 097 irrespective of age and sex, and CD4+ T cell Env-specific functionality scores were higher in HVTN 097. Env-specific CD40L+ CD4+ T cells were more common in HVTN 097, with individuals having this pattern of expression demonstrating higher median antibody responses to HIV-1 Env. IgG and IgG3 binding antibody rates and response magnitude to gp120 vaccine– and V1V2 vaccine–matched antigens were higher or comparable in HVTN 097 than in RV144 ADCC, and ADCP functional antibody responses were elicited in HVTN 097. Env-specific IgG and CD4+ Env responses declined significantly over time in both trials. Overall, cross-clade immune responses associated with protection were better than expected in South Africa, suggesting wider applicability of this regimen.

scholarly journals Potential To Streamline Heterologous DNA Prime and NYVAC/Protein Boost HIV Vaccine Regimens in Rhesus Macaques by Employing Improved Antigens

2016 ◽  
Vol 90 (8) ◽  
pp. 4133-4149 ◽  
Author(s):  
Benedikt Asbach ◽  
Alexander Kliche ◽  
Josef Köstler ◽  
Beatriz Perdiguero ◽  
Mariano Esteban ◽  
...  
Keyword(s):  
Clinical Trials ◽  
T Cell ◽  
Immune Responses ◽  
Rhesus Macaques ◽  
T Cell Responses ◽  
Hiv Vaccine ◽  
The Novel ◽  
Cell Responses ◽  
Protein Boost ◽  
Clade C

ABSTRACTIn a follow-up to the modest efficacy observed in the RV144 trial, researchers in the HIV vaccine field seek to substantiate and extend the results by evaluating other poxvirus vectors and combinations with DNA and protein vaccines. Earlier clinical trials (EuroVacc trials 01 to 03) evaluated the immunogenicity of HIV-1 clade C GagPolNef and gp120 antigens delivered via the poxviral vector NYVAC. These showed that a vaccination regimen including DNA-C priming prior to a NYVAC-C boost considerably enhanced vaccine-elicited immune responses compared to those with NYVAC-C alone. Moreover, responses were improved by using three as opposed to two DNA-C primes. In the present study, we assessed in nonhuman primates whether such vaccination regimens can be streamlined further by using fewer and accelerated immunizations and employing a novel generation of improved DNA-C and NYVAC-C vaccine candidates designed for higher expression levels and more balanced immune responses. Three different DNA-C prime/NYVAC-C+ protein boost vaccination regimens were tested in rhesus macaques. All regimens elicited vigorous and well-balanced CD8+and CD4+T cell responses that were broad and polyfunctional. Very high IgG binding titers, substantial antibody-dependent cellular cytotoxicity (ADCC), and modest antibody-dependent cell-mediated virus inhibition (ADCVI), but very low neutralization activity, were measured after the final immunizations. Overall, immune responses elicited in all three groups were very similar and of greater magnitude, breadth, and quality than those of earlier EuroVacc vaccines. In conclusion, these findings indicate that vaccination schemes can be simplified by using improved antigens and regimens. This may offer a more practical and affordable means to elicit potentially protective immune responses upon vaccination, especially in resource-constrained settings.IMPORTANCEWithin the EuroVacc clinical trials, we previously assessed the immunogenicity of HIV clade C antigens delivered in a DNA prime/NYVAC boost regimen. The trials showed that the DNA prime crucially improved the responses, and three DNA primes with a NYVAC boost appeared to be optimal. Nevertheless, T cell responses were primarily directed toward Env, and humoral responses were modest. The aim of this study was to assess improved antigens for the capacity to elicit more potent and balanced responses in rhesus macaques, even with various simpler immunization regimens. Our results showed that the novel antigens in fact elicited larger numbers of T cells with a polyfunctional profile and a good Env-GagPolNef balance, as well as high-titer and Fc-functional antibody responses. Finally, comparison of the different schedules indicates that a simpler regimen of only two DNA primes and one NYVAC boost in combination with protein may be very efficient, thus showing that the novel antigens allow for easier immunization protocols.

Local Knowledge and Experiences of Vaccination: Implications for HIV-Preventive Vaccine Trials in South Africa

2006 ◽  
Vol 34 (1) ◽  
pp. 108-123 ◽  
Author(s):  
Graham Lindegger ◽  
Michael Quayle ◽  
Moses Ndlovu
Keyword(s):  
South Africa ◽  
Religious Beliefs ◽  
Hiv Vaccine ◽  
Willingness To Participate ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials ◽  
Positive Attitudes ◽  
Preventive Vaccine ◽  
Kwazulu Natal ◽  
Negative Effect

This study forms part of the preparation of communities for HIV-preventive vaccine trials in South Africa. On the basis of the assumption that attitudes to any HIV vaccine or vaccine trials will partly be influenced by experiences of vaccination in general, this study aimed to investigate knowledge of, attitudes to, and experiences of vaccination in a small semirural community in KwaZulu-Natal, South Africa. The study also sought to investigate the effect of traditional, cultural, and religious beliefs on attitudes to vaccination, as well as to get some indication of willingness to participate in potential HIV vaccine trials. Overall, the findings reveal a good knowledge of, and positive attitudes to, vaccination, with little negative effect of traditional, cultural, and religious beliefs. The findings also reveal a generally positive attitude to HIV vaccines and vaccine trials. Barriers identified, such as anxiety about safety, were not surprising.

Counsellor-delivered HIV risk reduction intervention addresses safer sex barriers of people living with HIV in KwaZulu-Natal, South Africa

2011 ◽  
Vol 26 (12) ◽  
pp. 1623-1641 ◽  
Author(s):  
Deborah H. Cornman ◽  
Sarah Christie ◽  
Lindsay M. Shepherd ◽  
Susan MacDonald ◽  
K. Rivet Amico ◽  
...  
Keyword(s):  
South Africa ◽  
Risk Reduction ◽  
Hiv Risk ◽  
Safer Sex ◽  
People Living With Hiv ◽  
Hiv Risk Reduction ◽  
Kwazulu Natal ◽  
Risk Reduction Intervention ◽  
Living With Hiv

scholarly journals Review of preventative HIV vaccine clinical trials in South Africa

2020 ◽  
Vol 165 (11) ◽  
pp. 2439-2452
Author(s):  
Fatima Laher ◽  
Linda-Gail Bekker ◽  
Nigel Garrett ◽  
Erica M. Lazarus ◽  
Glenda E. Gray
Keyword(s):  
South Africa ◽  
Clinical Trials ◽  
Neutralizing Antibodies ◽  
Viral Vectors ◽  
Viral Vector ◽  
Passive Immunization ◽  
Hiv Infections ◽  
Aluminum Phosphate ◽  
Hiv Vaccine ◽  
Subtype C

AbstractNew HIV infections continue relentlessly in southern Africa, demonstrating the need for a vaccine to prevent HIV subtype C. In South Africa, the country with the highest number of new infections annually, HIV vaccine research has been ongoing since 2003 with collaborative public-private-philanthropic partnerships. So far, 21 clinical trials have been conducted in South Africa, investigating seven viral vectors, three DNA plasmids, four envelope proteins, five adjuvants and three monoclonal antibodies. Active vaccine candidates have spanned subtypes A, B, C, E and multi-subtype mosaic sequences. All were well tolerated. Four concepts were investigated for efficacy: rAd5-gag/pol/nef showed increased HIV acquisition in males, subtype C ALVAC/gp120/MF59 showed no preventative efficacy, and the trials for the VRC01 monoclonal antibody and Ad26.Mos4.HIV/subtype C gp140/ aluminum phosphate are ongoing. Future trials are planned with DNA/viral vector plus protein combinations in concert with pre-exposure prophylaxis, and sequential immunization studies with transmitted/founder HIV envelope to induce broadly neutralizing antibodies. Finally, passive immunization trials are underway to build on the experience with VRC01, including single and combination antibody trials with an antibody derived from a subtype-C-infected South African donor. Future consideration should be given to the evaluation of novel strategies, for example, inactivated-whole-virus vaccines.

scholarly journals Medical male circumcision and HIV risk: perceptions of women in a higher learning institution in KwaZulu-Natal, South Africa

Sexual Health ◽  
2013 ◽  
Vol 10 (2) ◽  
pp. 112 ◽  
Author(s):  
Joanne E. Mantell ◽  
Jennifer A. Smit ◽  
Jane L. Saffitz ◽  
Cecilia Milford ◽  
Nzwakie Mosery ◽  
...  
Keyword(s):  
South Africa ◽  
Hiv Risk ◽  
Male Circumcision ◽  
Risk Perceptions ◽  
Hiv Transmission ◽  
Medical Male Circumcision ◽  
Female Partners ◽  
Healing Period ◽  
Kwazulu Natal ◽  
The Impact

Background Medical male circumcision (MMC) reduces the risk of HIV acquisition for men in heterosexual encounters by 50–60%. However, there is no evidence that a circumcised man with HIV poses any less risk of infecting his female partner than an uncircumcised man. There may be an additional risk of HIV transmission to female partners during the 6-week healing period and if condoms are used less often after circumcision. The aim was to explore young women’s perspectives on MMC, with a view to developing clear messages about the limitations of MMC in reducing women’s HIV risk. Methods: We explored women’s perspectives on MMC in KwaZulu-Natal, South Africa, with a sample of 30 female tertiary students via four focus groups (two for women only; two mixed gender). Results: In all groups, women communicated a thorough understanding of the partial efficacy of MMC, but believed that others would not understand this concept. Participants noted that MMC affords no direct benefit to women. Most thought that MMC would increase females’ risk of contracting HIV, that circumcised men may engage in risky behaviours and that men would increase their number of sexual partners after circumcision. Participants believed that condom use would decrease after MMC and speculated that men would have sex during the healing period, which could further compromise women’s sexual health. Conclusion: The concerns expressed by women regarding MMC highlight the need for including women in the dialogue about MMC and for clarifying the impact of MMC on HIV risk for women.

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