Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E
Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: ALVAC-HIV (Biological); AIDSVAX B/E (Biological); ALVAC-HIV Placebo (Biological); AIDSVAX B/E Placebo (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: U.S. Army Medical Research and Materiel Command Official(s) and/or principal investigator(s): Punnee Pitisuttithum, MD, DTM&H, Principal Investigator, Affiliation: Mahidol University
Overall contact: Punnee Pitisuttithum, MD, DTM&H, Phone: 66 8 1829 4906, Email: punnee.pit@mahidol.ac.th
Summary
The primary purpose of the study is to better define the relative contributions of AIDSVAX®
B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed
immune profile in the weeks and months after receiving the original prime and boost vaccine
regimen from study protocol RV 144, and their booster effects in both the systemic and
mucosal compartments. In addition, this study will provide more intensive and comprehensive
characterization of the innate, cell-mediated and humoral immune responses than possible
within the RV 144 study.
Clinical Details
Official title: Randomized, Double Blind Evaluation of Different One-Year Boosts After Sanofi Pasteur Live Recombinant ALVAC-HIV (vCP1521) and Global Solutions for Infectious Diseases (GSID) gp120 B/E (AIDSVAX® B/E) Prime-Boost Regimen in HIV-uninfected Thai Adults
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Change in Immune ResponseChange in Humoral Immune Response
Secondary outcome: Safety Monitoring
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy, HIV-uninfected male and female volunteers between age 20 and 40, weighing
over 45 kilograms, and available for a period of 24 months and having a Thai identity
card.
2. Must be at low risk for HIV infection per investigator assessment.
3. Must be able to understand and complete the informed consent process.
4. Must be capable of reading Thai.
5. Must successfully complete a Test of Understanding prior to enrollment.
6. Must be in good general health without clinically significant medical history.
7. HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
8. Laboratory screening analysis:
- Hemoglobin: Women ≥12. 0 g/dL, Men ≥12. 5 g/dL
- White cell count: 4,000 to 11,000 cells/mm^3
- Platelets: 150,000 to 450,000/mm^3
- ALT and AST ≤1. 25 institutional upper limit of reference range
- Creatinine: ≤1. 25 institutional upper limit of reference range
- Urinalysis (dipstick) for blood and protein no greater than 1+ and negative
glucose.
9. Female-Specific Criteria:
- Negative pregnancy test for women at screening and prior to each
vaccination(same day)and prior to any of the invasive procedures.
- Be using adequate birth control methods for 45 days prior to the first
vaccine/placebo vaccination and for at least 3 months after the final
vaccine/placebo vaccination. Adequate birth control is defined as follows:
Contraceptive medications delivered orally, intramuscularly, vaginally, or
implanted, underneath the skin, surgical methods (hysterectomy or bilateral
tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence.
Exclusion Criteria:
1. Asplenia: any condition resulting in the absence of a functional spleen.
2. Bleeding disorder diagnosed by a medical doctor (e. g., factor deficiency,
coagulopathy, or platelet disorder requiring special precautions).
3. Therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international
normalized ration (INR) of partial prothrombin time (PTT).
4. Women breast-feeding or pregnant (positive pregnancy test) or planning to become
pregnant during the window between study enrollment and 3 months after the last
vaccination visit.
5. History of anaphylaxis or other serious adverse reaction to vaccines or allergies or
reactions likely to be exacerbated by any component of the vaccine or placebo,
including eggs, egg products, streptomycin, or neomycin.
6. Subject has received any of the following substances:
- Chronic use of therapies that may modify immune response, such as IV
immuneglobulin and systemic corticosteroids (in doses of > 20 mg/day prednisone
equivalent for periods exceeding 10 days). The following exceptions are
permitted and will not exclude study participation: use of corticosteroid nasal
spray for rhinitis, topical corticosteroids for an acute uncomplicated
dermatitis; or a short course (duration of 10 days or less, or a single
injection) of corticosteroid for a non-chronic condition (based on investigator
clinical judgment) at least 2 weeks prior to enrollment in this study.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulins within 30 days prior to HIV screening.
- Any licensed vaccine within 14 days prior to initial study vaccine
administration in the present study.
- Receipt of any investigational HIV vaccine.
- Investigational research agents or vaccine within 30 days prior to enrollment in
the present study.
- Anti-tuberculosis prophylaxis or therapy during the past 90 days prior to
enrollment.
7. Active sexually transmitted infection confirmed by clinical exam and diagnostic test.
8. Any medical, psychiatric, social condition, occupational reason, or other
responsibility that, in the judgment of the investigator, is a contradiction to
protocol compliance or impairs a subject's ability to give informed consent.
9. Psychiatric condition that precludes compliance with the protocol; past or present
psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5
years prior to enrollment, a history of suicide ideation or attempt.
10. Study site employees who are involved in the protocol and/or may have direct access
to study related area.
Locations and Contacts
Punnee Pitisuttithum, MD, DTM&H, Phone: 66 8 1829 4906, Email: punnee.pit@mahidol.ac.th
Royal Thai Army Clinical Research Center, AFRIMS, Bangkok 10400, Thailand; Recruiting Narongrid Sirisopana, MD, Phone: +66-81-908-6888, Email: NarongridS@afrims.org Sorachi Nitayaphan, MD, PhD, Principal Investigator Jintanat Ananworanich, MD, PhD, Sub-Investigator Narongrid Sirisopana, MD, Sub-Investigator
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Recruiting Punnee Pitisuttithum,, MD, DTM&H, Phone: +66 8 1829 4906, Email: punnee.pit@mahidol.ac.th Punnee Pitisuttithum, MD, DTM&H, Principal Investigator Benjaluck Phonrat, MS, Sub-Investigator Jittima Dhitavat, MD, Sub-Investigator Supat Chamnanchanunt, MD, DTM&H, Sub-Investigator Vipa Thanachartwet, MD, Sub-Investigator Viravarn Luvira, MD, Sub-Investigator
Research Institute for Health Sciences (RIHES), Chiang Mai University, Chiang Mai 50202, Thailand; Recruiting Suwat Chariyalertsak, MD, DrPH, Phone: +66 850 404 524, Email: schariya@med.cmu.ac.th Suwat Chariyalertsak, MD, DrPH, Principal Investigator Natthapol Kosashunhanan, MD, Sub-Investigator Nuntisa Chotirosniramit, MD, Sub-Investigator
Additional Information
Related publications: Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20. Rerks-Ngarm S, Paris RM, Chunsutthiwat S, Premsri N, Namwat C, Bowonwatanuwong C, Li SS, Kaewkungkal J, Trichavaroj R, Churikanont N, de Souza MS, Andrews C, Francis D, Adams E, Flores J, Gurunathan S, Tartaglia J, O'Connell RJ, Eamsila C, Nitayaphan S, Ngauy V, Thongcharoen P, Kunasol P, Michael NL, Robb ML, Gilbert PB, Kim JH. Extended evaluation of the virologic, immunologic, and clinical course of volunteers who acquired HIV-1 infection in a phase III vaccine trial of ALVAC-HIV and AIDSVAX B/E. J Infect Dis. 2013 Apr 15;207(8):1195-205. doi: 10.1093/infdis/jis478. Epub 2012 Jul 26.
Starting date: September 2013
Last updated: April 21, 2015
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