Oral Abstract Session 01 - Global HIV Vaccine Enterprise

POSTERS
Posters
Topic 4: Clinical Vaccine Trials and Trial Site Challenges
P04.15
Uptake and Tolerability of Repeated Mucosal
Specimen Collection In Two Phase 1 AIDS Preventive
Vaccine Trials In Kenya
G. Mutua 1 , G. Omosa-Manyonyi 1 , H. Park 2 , P. Bergin 3 ,
D. Laufer 2 , P.N. Amornkul 2 , J. Lehrman 2 , P. Fast 2 , J. Gilmour 3 ,
O. Anzala 1 , B. Farah 1
1 Kenya AIDS Vaccine Initiative, Nairobi, Kenya; 2 International
AIDS Vaccine Initiative, New York, NY, USA; 3 International AIDS
Vaccine Initiative Human Immunology Laboratory, London,
United Kingdom (Great Britain)
Background: Mucosal specimens are useful to evaluate local
immune responses in AIDS preventive vaccine trials, but the
acceptability and tolerability of mucosal sampling in Africa
remains unknown.
Methods: The Kenya AIDS Vaccine Initiative (KAVI) initiated two
AIDS preventive vaccine trials in Nairobi in 2011. After informed
consent for a mucosal substudy, participants were asked to
provide any of several types of mucosal secretions: saliva, oral
fluids, semen, cervico-vaginal and rectal. Specimens were
collected at baseline, one month after final vaccination, and at
the next scheduled trial visit. A tolerability questionnaire was
administered at the final visit.
Results: Of 80 trial participants, 65(81.3%) consented to
the mucosal sub-study and provided at least one specimen,
7/65(10.8%) gave all specimens at least once and 2/65(3.1%)
gave all possible specimens at all visits. Saliva and oral fluids
were given at all time-points by 62/65(95.4%) participants. Of 48
men, 21(43.8%) provided semen at baseline, 18/21 completed
all 3 time-points. Of 17 women, 15(88.2%) gave vaginal sponge
and SoftCup specimens at least once; 8/15(53.3%) gave both at
all eligible time-points. Rectal sampling was the least acceptable
method: 13/65(20%) participants agreed at baseline [4/17
women (23.5%), 9/48 men (18.8%)]. Of these, 4 men and 2
women gave samples at all time-points. The most common reason
for accepting mucosal sampling was a desire to contribute to HIV
research and for refusal, embarrassment/emotional discomfort.
Conclusion: Repeated saliva, oral fluid, semen and cervico-vaginal
mucosal sampling in AIDS vaccine preventive trials in Kenya is
feasible; this study however re-affirms the challenge of repeated
rectal mucosal sampling in low-risk participants, noted in an
earlier observational study at KAVI (AIDS Vaccine 2010 P10.07).
Possible explanations include cultural and religious reasons
contributing to embarrassment and emotional discomfort in lowrisk
participants. Including more qualitative research in vaccine
trials with mucosal sampling could help elucidate these findings.
156
AIDS Vaccine 2012
P04.16
Feasibility of Recruiting High-Risk Women in the US
for HIV Vaccine Efficacy Trials (HVTN 906)
B. Koblin 1 , B. Metch 2 , C. Morgan 3 , R. Novak 4 , E. Swann 5 ,
D. Metzger 6 , D. Lucy 1 , D. Dunbar 6 , P. Graham 4 , T. Madenwald 3 ,
G. Escamia 2 , I. Frank 6
1 New York Blood Center, New York, NY, USA; 2 SCHARP / Fred
Hutchinson Cancer Research Center, Seattle, WA, USA; 3 HIV
Vaccine Trials Network / Fred Hutchinson Cancer Research
Center, Seattle, WA, USA; 4 University of Illinois at Chicago,
Chicago, IL, USA; 5 Division of AIDS, NIAID, NIH, Bethesda, MD,
USA; 6 University of Pennsylvania, Philadelphia, PA, USA
Background: Identifying women in the US with sufficient risk of
HIV infection for inclusion in HIV vaccine efficacy trials has been
challenging. Using geography and sexual network characteristics
to inform new recruitment strategies, HVTN 906 determined
the feasibility of recruiting and retaining women at high risk and
assessed HIV incidence.
Methods: HIV uninfected women were enrolled in Chicago, New
York City and Philadelphia if they were 18-45 years, not pregnant
or intending to become pregnant for 18 months and reported
unprotected vaginal/anal sex in the prior six months and either
i) resided or engaged in risk behavior in local geographical HIV
risk pockets; and/or ii) had a male partner who had either been
incarcerated or injected drugs in the last year or had concurrent
sex with another partner in the last six months. Behavioral risk
assessment, risk reduction counseling, HIV and pregnancy testing
were done at baseline, 6, 12 and 18 months.
Results: Among 799 women, 71% were from local high-risk pockets
and had high-risk male partners, 18% were from local high-risk
pockets only and 10% had high-risk male partners only. Median
age was 37 years; 79% were Black and 15% Latina. At baseline,
the median number of male partners was 3 (25%,75%: 2,7), 76%
had unprotected sex while intoxicated (alcohol or drugs), and
52% exchanged sex for money or drugs. Retention at 18-months
was 80%. Pregnancy incidence was 11% with 48% of pregnancies
occurring during the first 6 months of follow-up. HIV incidence
was 0.31% (95% CI: 0.06,0.91). Risk behaviors decreased between
screening and 6 months with little change thereafter.
Conclusion: Women recruited using new strategies based on
geography and sexual network characteristics did not have
a substantial HIV incidence, despite baseline levels of risk
behaviors. New strategies to identify women at high risk in the
US are needed.