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Oral Abstract Session 01 - Global HIV Vaccine Enterprise

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POSTERS<br />

Posters<br />

Topic 9: Non-<strong>Vaccine</strong> Prevention<br />

P09.17<br />

Female Sex Workers and Condom Use: Lessons for<br />

Future <strong>HIV</strong> <strong>Vaccine</strong> Trial in Nigeria<br />

O. Fakunle 1 , A. Adeyemi 2 , O. Busari 3 , O. Adesola 4<br />

1 University College Hospital, Ibadan, Nigeria; 2 MEASURE,<br />

Abuja, Nigeria; 3 Federal Medical Center, Ido-Ekiti, Nigeria;<br />

4 Mainland Hospital, Lagos, Nigeria<br />

Background: Condom remains one of the most effective means<br />

of <strong>HIV</strong> prevention in the absence of proven, safe and effective<br />

vaccine. Nigeria has a surveillance system that monitors <strong>HIV</strong><br />

trend among most-at-risk populations. Female sex workers (FSW)<br />

have the highest <strong>HIV</strong> prevalence compared to other groups. Since<br />

the ultimate goal is to prevent new infection, there is a need to<br />

evaluate condom use among FSW and the lessons will be vital for<br />

future <strong>HIV</strong> vaccine trial.<br />

Methods: Secondary data analysis of 2<strong>01</strong>0 Integrated Bio-<br />

Behavioral Surveillance Survey was done with 4559 brothel<br />

and non-brothel FSWs in 9 Nigerian states. The survey involved<br />

<strong>HIV</strong> testing. Administered questionnaires had information on<br />

socio-demographic, <strong>HIV</strong>, sexual/reproductive health variables.<br />

Predictors of consistent condom use were evaluated using<br />

multiple logistic regression models.<br />

Results: The median age was 26years (15-49years); median age<br />

at first sex was 17years (11-22years); average clients/day was<br />

4; 38% had ever been married with 8.1% currently married and<br />

3.7% living with their spouse; 74.6% used condom consistently;<br />

47.4% completed at least secondary education; 53.6% had been<br />

away from home for more than 1month; 60.2% tested and<br />

received <strong>HIV</strong> result within the last 12months; and 91.2% knew<br />

that condom could protect against <strong>HIV</strong>. Significant predictors of<br />

consistent condom use include testing and knowing result for<br />

<strong>HIV</strong> OR=1.9 95%CI:1.4-2.5; being away from home for ≥1month<br />

OR=1.4 95%CI:1.1-1.9; engaged in sex trade for 24months or<br />

less OR=2.7 95%CI:2.0-3.7; those that had 4 or more clients per<br />

day OR=1.7 95%CI:1.3-2.3) and those aged 25years and above<br />

OR=1.4 95%CI:1.1-2.1.<br />

Conclusion: Older FSW with shorter duration in sex trade, having<br />

more clients, aged above 25years and away from home are more<br />

likely to use condom consistently. Lessons from condom uptake<br />

among FSW may lead to targeting FSW with these features for<br />

inclusion criteria for <strong>HIV</strong> vaccine trial in Nigeria.<br />

208<br />

AIDS <strong>Vaccine</strong> 2<strong>01</strong>2<br />

P09.18 LB<br />

Infrequent, Low Magnitude <strong>HIV</strong>-Specific T Cell<br />

Responses In <strong>HIV</strong>-Uninfected Participants In The 1%<br />

Tenofovir Microbicide Gel Trial (CAPRISA004)<br />

W.A. Burgers 1 , T.L. Muller 1 , A. Kiravu 1 , V. Naranbhai 2 ,<br />

S. Sibeko 2 , L. Werner 2 , Q. Abdool Karim 2 , S.S. Abdool Karim 2<br />

1 University of Cape Town, Cape Town, South Africa; 2 CAPRISA,<br />

Nelson R Mandela School of Medicine, Durban, South Africa<br />

Background: Macaque studies of antiretroviral-containing<br />

microbicide gels administered rectally or vaginally followed by SIV<br />

challenge have documented priming of SIV-specific T cell responses<br />

in the blood of protected animals. This concept has been termed<br />

“chemo-vaccination”, where aborted viral replication is thought<br />

to leave an immune footprint of exposure, which may augment<br />

protection provided by microbicides/PrEP. We investigated<br />

whether T cell responses were detectable in women participating<br />

in CAPRISA004 1% tenofovir microbicide trial, which showed 39%<br />

efficacy in reducing <strong>HIV</strong> acquisition.<br />

Methods: Thirty-eight <strong>HIV</strong>-uninfected participants were selected<br />

based on consistently high gel use and a high number of recorded<br />

sex acts over the duration of the trial. Cryopreserved PBMC were<br />

stimulated with <strong>HIV</strong>-1 peptide pools based on the <strong>HIV</strong>-1 clade<br />

C proteome, and IFN-gamma production was measured by the<br />

ELISPOT assay. Positive response were defined as >55 SFU/106<br />

PBMC. Samples were tested at the visit at which preceding<br />

monthly coital activity was the participant’s highest, and at study<br />

exit. Assays were conducted blinded to placebo or tenofovir arm.<br />

Results: T cell responses were detected in 1/18 tenofovir and<br />

2/13 placebo participants at the high gel use visit. Responses<br />

were of low magnitude (between 60 and 100 SFU/106 PBMC),<br />

and directed at peptide pools from <strong>HIV</strong> Gag, Pol, Nef and Env.<br />

T cell responses were not detected at the exit visit. These data<br />

suggest that <strong>HIV</strong>-specific responses are infrequently detected<br />

in blood in uninfected participants from a clinical trial of a<br />

vaginal microbicide, and where present, are of low magnitude<br />

and transient.<br />

Conclusion: Magnitude and timing of viral exposure may account<br />

for differences in detecting systemic T cell responses between<br />

preclinical studies in non-human primates and a human clinical<br />

trial of a vaginal microbicide.

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