Abstract Book Vol. 2 [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

XIV International AIDS Conference

Abstracts WePeB6051-WeOrC1l267 91

Presenting author: Patrick Smith, 219 Cooke Hall, University at Buffalo School
of Pharmacy, Buffalo, NY 14260, United States, Tel.: [phone], Fax: +1
716 845 2336, E-mail: [email protected]
WePeB6051 I Safety and immunogenicity of live recombinant
ALVAC-HIV (vCP 1521) priming with gp 120
boosting in Thai HIV seronegative adults
V. Suriyanon1, RP. Thongcharoen2, C. Khamboonruang1, M. de Souza3,
S. Gurunathan4, S. Kim-Ratto5, J. Kim6, A.M. Duliege7, A.E. Brown8, The Thai
AIDS Vaccine Evaluation Group9. I Research Institute for Health Sciences,
Chiang Mai University Research Institute for Health Sciences, Chiang Mai
University, P O. Box 80 CMU., Chiang Mai, 50202, Thailand; 2 Mahidol University
Thailand, Bangkok, Thailand; 3AFRIMS, Bangkok, Thailand; 4Aventis Pasteur,
Swiftwater, PA, United States; 5Henry M. Jackson Foundation, Rockville, MD,
United States; 6 WRAIR, Rockville, MD,; 7Chiron Vaccines, Emeryville, CA,
United States; 8AFRIMS, Bangkok, Thailand; 9TAVEG, Chiang Mai, Bangkok
Background: Several phase 1/11 trials of ALVAC-HIV candidate vaccines alone
or boosted with soluble protein antigens have demonstrated the safety and immunogenicity subtype B prime-boost vaccine candidates. The predominance of
subtype E infections in Thailand suggests that prime-boost vaccine candidates
appropriate for use in Thailand should contain subtype E antigens.
Objective: To evaluate the safety, tolerability and immunogenicity of subtype E
based Aventis Pasteur live recombinant ALVAC-HIV (vCP1521) prime and Chiron
gp120 CM235/SF2 E/B bivalent boost in HIV-seronegative Thai adults.
Methods: The study was double blind, randomized, placebo controlled. ALVAC
or its placebo was given IM at weeks 0, 4, 12, and 24. gp120 or placebo was
given at weeks 12 and 24. Reactogenicity and safety data were collected. Preand post-vaccination sera were tested for binding/neutralizing Ab, PBMCs for LPA
and CTL responses.
Results: 62 volunteers were enrolled (46 vaccinees and 16 placebo recipients).
Reactogenicity was mild-to-moderate in the overwhelming majority of cases.
There were 6 SAEs, all unrelated to vaccination. The AE profile confirms the
safety of ALVAC constructs seen in previous studies. No vaccinations were withheld due to reactions or intolerance. In one case, the 4th vaccination was withheld due to microscopic hematuria, unknown etiology. NAbs against subtype E
strains were detected in 98% and against SF2 strain in 60% of the vaccinees.
LPA responses to CM 235 and to SF2 antigens developed in 69% and 64% of the
vaccinees respectively. CTLs are currently being analyzed.
Conclusions: The prime boost vaccine combination of Aventis Pasteur ALVACHIV (vCP1521) and Chiron HIV Thai E (CM 235) gpl20 + SF2 gpl20 appeared
safe and well tolerated in healthy Thai adults. Good immunogenicity was shown
by neutralization assay and LPA. The safety profiles and the immunogenicity of
this prime boost vaccine combination is appropriate for advancement to phase Ill
testing.
Presenting author: Vinai Suriyanon, Research Institute for Health Sciences, Chiang Mai University, P.O. Box 80 CMU., Chiang Mai, 50202, Thailand, Tel.: [phone], 894792, Fax: [phone], 892298, E-mail: [email protected]
WePeB6052 Experience with recruitment of HIV vaccine
volunteers in Trinidad and Tobago
N. Jack1, H. Smith', J. Edwards', A. Quaval, F Campbell1, J. Jwang1,
Y. Simon', C. Francis', W. Blattner2, F. Cleghorn2, C. Bartholomew3. 1Meal
Research foundationdic, Port of Spain, Trinidad and Tobago; 2nstitute Of
Human Virology, Maryland, United States; 3Medical Research Foundation, Port
of Spain, Trinidad and Tobago
Issues: Developing countries are participating in the global search for an HIV vaccine and recruitment can present challenges, especially in face of past historical
events in Tuskegee.
Description: Trinidad and Tobago is one of the current HVTN HIV vaccine trial
sites conducting a Phase II HIV vaccine trial with the Aventis Pasteur's vCP1452
vaccine boosted with AIDSVAX gpl20. After 3 years of community education and
a rigorous approval process, locally and internationally, active recruitment began
in April 2001. Only healthy volunteers at low risk for HIV acquisition are eligible.
As of January 15, 2002, there were 94 volunteers, ages between 19 and 53, with
over 95% volunteering for altruistic reasons. The major reason for volunteering
related to having had at least one family member or friend infected with HIV %).
High risk behavioral eliminated 36. (17), medical exclusion (11), and excluded because of inability to negotiate time off from work (9). After hearing details of the
protocol 10 expressed no further interest. Of the 47 eligible volunteers, 37 have
proceed to full screening, 1 died, 2 migrated and 7 were no longer interested.
Following screening, 12 more were ineligible for medical reasons usually due to
minor perturbations in safety laboratory measurements.
Lessons learnt: Volunteers for HIV vaccine trials are generally people "touched"
by HIV. Because the criteria for this phase II trial is very strict, almost half of the
volunteers have been found to be in-eligible for participation.

Recommendation: The range of laboratory values in a developing world appears
to have a broader range and exclusion criteria for minor laboratory perturbations
in safety laboratories should be assessed and broadened where the health of
a participant is not jeopardized by broadening the range of such criteria. Phase
1/11 studies with strict enrollment criteria cannot be used to assess recruitment
capacity for Phase III trials.

Presenting author: noreen jack, medical research foundation, 7 queens park
east, port of spain, Trinidad and Tobago, Tel.: [phone], Fax: [phone], E-mail: [email protected]
WePeB6053 The first HIV clade A vaccine in a clinical trial:
Induction of HIV-specific T cell responses
T Hanke, A.J. McMichael, M. Mwau, I. Cebere, E.G.T. Wee, S. Patel, J. Sutton,
H. McShane, M. Brooks, M. Tomlinson, J. Roberts. MRC Human Immunology
Unit, Weatherall Institute of Molecular Medicine, Oxford, United Kingdom
Background: Development of an effective preventive HIV vaccine remains the
most pressing challenge in modern medicine. Virus-specific CD8+ cytotoxic T
lymphocytes (CTL) play an important role in the control of HIV replication.
Methods: We have found that a successive immunization with DNA- and modified
vaccinia virus Ankara (MVA)-based vaccines expressing a common immunogen
is a potent way of inducing CD8+ CTL. With the view of proceeding into a highrisk cohort in Kenya for the efficacy trial, we designed the immunogen for clinical
use, termed HIVA, to match the HIV strain responsible locally for over 70% of
infections. It consists of a consensus clade A gag p24/p17 and a string of clade
A-derived CTL epitopes.
Results: Pre-clinical studies in mice and rhesus macaques demonstrated high
immunogenicities of both the pTHr.HIVA and MVA.HIVA vaccines. In phase I trials in healthy low-risk volunteers, both vaccine components alone induced respectable T cell responses in a majority of volunteers. The results of the first arms
of the HIVA trials and the readout interferon-g ELISPOT assay will be discussed.
Conclusions: We are encouraged by the immunogenicity of the individual vaccine components even before their combination into a heterologous prime-boost
regimen.
The work has been supported by MRC UK and IAVI.
Presenting author: tomas hanke, MRC Human Immunology Unit, Weatherall
Institute of Molecular Medicine, Oxford OX3 9DS, United Kingdom, Tel.: +44
(0)1865 222355, Fax: [phone], E-mail: [email protected]
WePeB6054I Pericarditis in AIDS children
R. Costa, A. Popoiu, G. Doros, M. Gafencu, C. Popoiu, M. Serban. 3rd Pediatric
Clinic Timisoara, Bogdanesti/or str. 2, sc. B, ap 20, 1900 Timisoara, Romania
Background: Inflammation of the pericardium could be a frequent manifestation
of HIV infection among adults, but less common in children. The cause of pericardial effusion may be inflammatory in origin, due to sepsis, may be due to thyroid
abnormalities or, to represent an abnormality of immune system.
Material and Method: During 1990-2001 in our Clinic were admitted 530 children
with HIV infection, with age between 3 months and 16 years old. Ten children
(1.88%) were diagnosed with pericarditis. They were aged between 10-15 years
and sex ratio was 3 male and 7 female. The diagnosis was made based on clinical findings, EKG, echocardiogram and chest x-ray. In 2 cases was performed
pericardiocentesis for diagnostic and/or therapeutically reasons.
Results: All children were in stage C of HIV infection; 8 cases had CD4 bellow
200/mmc. For 3 of them the diagnosis of pericarditis was 1 week prior to HIV infection. In 4 cases pericarditis was associated to dilatative cardiomiopaty In 8 cases
we couldn't find the etiological agent; in 2 cases tuberculosis was the cause of
pericarditis. In one case the pericardial effusion exhibit with cardiac tamponade.
Five cases (50%) died in a period of 6 to 12 months.
Conclusion: In the last period of time we realize an increase of the incidence
of pericarditis in AIDS children that is possible due to the long evolution of HIV
infection (10-12 years) correlated with the immune destruction. 2/3 of the cases
was oligo- or asympthomatic. The prognosis is poor.
Presenting author: Costa Rodica, Bogdanestilor str. 2, sc. B, ap 20, 1900
Timisoara, Romania, Tel.: [phone], E-mail: [email protected]
WeOrC1267 New tools for monitoring national seroprevalence
of HIV: Result of the 2001 mali demographic and
health survey
G. Pappas1, I. Niambele2, C. Ryan3, F Bougoudogo2, E. Baganizi3,
G. Bicego1, C.C. Aboulafia1, A. Sharman4, M. Ayad1. 1ORC Macro, 11785
Beltsville Drive, Calverton, Maryland, 20705, United States; 2Ministry of Health,
Bamuko, Mali; 3Center for disease control and prevention, Atlanta, Georgia,
United States; 4 USAID, Almaty Kazakhstan
Background: National population-based surveys provide an opportunity for improved information on the dynamics of the HIV/AIDS epidemic in developing
countries. Over the past decade the Demographic and Health Survey (DHS) began supplying national population-based estimates of levels of knowledge and
attitudes related to HIV/AIDS, and risk behaviors have been based on questionnaire data for many developing countries. Over 150 Demographic and Health Sur
veys have been conducted in more than 50 countries since the inception of the
program in 1983. The prospects for inclusion of HIV testing in national populationbased surveys to produce national sero-prevalence rates will be explored in this
paper.
Methods: The Mali DHS 2001 was a nationally representative sample of 7807
persons that included study of knowledge, attitudes, and practices related to
HIV/AIDS and HIV testing in the country Fingerpick blood on cotton filter paper