Oral Abstract Session 01 - Global HIV Vaccine Enterprise

POSTERS
Posters
Topic 4: Clinical Vaccine Trials and Trial Site Challenges
P04.23 LB
Screen Failure in Phase I HIV Clinical Trials In Soweto,
South Africa: An Opportunity For Care
F. Laher 1 , M. Mamba 1 , K. Otwombe 1 , G.E. Gray 1
1 Perinatal HIV Research Unit, Johannesburg, South Africa
Background: Reasons for screen failures are evaluated for
three phase 1 HIV vaccine clinical trials recruiting healthy lowrisk
participants at the Perinatal HIV Research Unit: SAAVI102/
HVTN073 and SAAVI103/HVTN086 (the first trials evaluating
a Clade C vaccine, Novartis Subtype C gp140 with MF59
adjuvant boosting SAAVI DNA-C2 and SAAVI MVA-C vaccine)
and IAVIB003/HVTN091 (Ad26 and Ad35 ENV vaccines).
Recruitment strategies involved a pre-screening programme,
clinics and community outreach.
Methods: Protocol-specific eligibility was determined using
assessments of understanding, risk behaviour, medical
history, physical examination, blood and urine testing, and for
HVTN073 and 086, electrocardiograms. Descriptive analysis and
multivariate logistic regression of age, trial group and gender
were performed.
Results: Between June 2009-2012, 225 participants(females=24%),
median age 22 years(IQR:20-25) were screened. Overall 53%
were ineligible, 60% of females vs. 51% of males (p=0.2). Site
screening-to-enrolment ratios for 073, 086 and 091 were
2.1:1, 2.3:1 and 1.7:1 respectively. Medical abnormalities
contributed 59% (n=70) of ineligibility reasons, chiefly urine
abnormalities (n=12/70 where eleven displayed microscopic
blood/haemoglobin, seven with leucocyte esterase and one had
proteinuria), abnormal ECG (n=12), raised liver enzymes (n=10),
raised blood pressure (n=9), low white cells (n=8) and hepatitis
B (HBsAg+ve) or C (anti HCV+) (n=7). Other criteria excluded
41%(n=49) e.g. incomplete screening before enrolment closure
(n=16), high-risk sexual behaviors (n=15), inability to comply with
protocol (n=11), enrolment in another study (n=3), substance
abuse (n=2, both cannabis-users), and poor understanding (n=2).
In multivariate analysis, increasing age (OR 1.081, CI:1.007-1.16,
p=0.032) predicted ineligibility but gender did not (OR: 0.67, CI:
0.35-1.3, p=0.24). HVTN073&086 participants were more likely
to be ineligible than HVTN091 (OR 2.2, CI:1.1-4.5, p=0.023).
Conclusion: Screen failures in phase 1 vaccine trials in Soweto
provide young people opportunities for care, especially through
blood pressure, urine, risk behaviour and hepatitis B/C screening.
Older participants and those in protocols stipulating ECG criteria
were more likely to fail screening.
160
AIDS Vaccine 2012
P04.24 LB
HIV Vaccine Trial Safety And Retention Among 18-20
Year Olds In The HVTN 503/Phambili Study Support
The Inclusion Of Adolescents In Future Trials
J.E. Volk 1 , N.A. Hessol 2 , G.E. Gray 3 , J.G. Kublin 4 , G. Churchyard 5 ,
K. Mlisana 6 , M. Nchabeleng 7 , S.P. Buchbinder 8 , L. Bekker 9
1 University of California, San Francisco, San Francisco, CA,
USA; 2 Departments of Clinical Pharmacy and of Medicine,
UCSF, San Francisco, CA, USA; 3 Perinatal HIV Research
Unit, University of Witwatersrand, Johannesburg, South
Africa; 4 HIV Vaccine Trials Network, Fred Hutchinson Cancer
Research Center, Seattle, WA, USA; 5 Aurum Institute for
Health Research, Klerksdorp, South Africa; 6 Department of
Medical Microbiology, University of KwaZulu-Natal, Congella,
South Africa; 7 Medunsa HIV Clinical Research Unit, University
of Limpopo, Limpopo, South Africa; 8 Department of Public
Health, HIV Research Section, San Francisco, CA, USA; 9 The
Desmond Tutu HIV Centre, University of Cape Town, Cape
Town, South Africa
Background: Worldwide, many adolescents, especially women,
acquire HIV before age 18. Yet to date, no HIV vaccine trials have
enrolled adolescents. Reasons for excluding adolescents from
these trials include regulations protecting vulnerable subjects
and concerns regarding informed consent, social harms, adverse
events, and loss to follow-up.
Methods: Using data from the HVTN 503/Phambili study, a
multisite phase 2b double-blind RCT in South Africa, motivations
for joining the trial, adverse events, social harms, and loss to
follow-up were compared between young adults (18-20 years-old)
and adults ≥21 years-old using bivariate and multivariate analyses.
Results: Young adults (n=238) were less likely than older
participants (n=563) to report joining the vaccine trial for
monetary incentives (10.5% vs. 16.3%, p