Trial record 18 of 40 for:    " August 17, 2011":" September 16, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01435135
First received: September 8, 2011
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.


Condition Intervention Phase
HIV Infections
Biological: ALVAC-HIV
Biological: AIDSVAX B/E
Biological: ALVAC-HIV Placebo
Biological: AIDSVAX B/E Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind Evaluation of Late Boost Strategies for HIV-uninfected Participants in the HIV Vaccine Efficacy Trial RV 144: "Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults"

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Primary Immunogenicity Endpoint [ Time Frame: Baseline, Weeks 2, 24, 26, 48 and 72 ] [ Designated as safety issue: No ]
    Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT and intracellular cytokine staining (ICS).

  • Safety Endpoints [ Time Frame: During the 3 days post-vaccination ] [ Designated as safety issue: Yes ]
    Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards.


Secondary Outcome Measures:
  • Secondary Immunogenicity Endpoints [ Time Frame: Baseline, Weeks 2, 24, 26, 48 and 72 ] [ Designated as safety issue: No ]
    Characterization of vaccine-induced immune responses by lymphoproliferation assays (LPA), human leukocyte antigen (HLA) subtyping, characterization of natural killer (NK) cells using multiparameter flow, assessment of APOBEC 3G (A3G) antiretroviral factor expression, B-cell ELISPOT, HIV-specific binding antibody assays, neutralizing antibody assays, mucosal IgG and IgA binding antibody assays, antibody-dependent cell mediated cytotoxicity (ADCC) and antibody-dependent cell mediated viral inhibition (ADCVI) assays


Estimated Enrollment: 162
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
ALVAC-HIV + AIDSVAX B/E or ALVAC-HIV placebo + AIDSVAX B/E placebo at Weeks 0 and 24
Biological: ALVAC-HIV
1 mL per injection containing 10^6 CCID50/dose administered
Other Name: (vCP1521)
Biological: AIDSVAX B/E
1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
Biological: ALVAC-HIV Placebo
1 ml per injection
Biological: AIDSVAX B/E Placebo
1 ml per injection
Experimental: Group II
AIDSVAX B/E or AIDSVAX B/E placebo at Weeks 0 and 24
Biological: AIDSVAX B/E
1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
Biological: AIDSVAX B/E Placebo
1 ml per injection
Experimental: Group III
ALVAC-HIV or ALVAC-HIV placebo at Weeks 0 and 24
Biological: ALVAC-HIV
1 mL per injection containing 10^6 CCID50/dose administered
Other Name: (vCP1521)
Biological: ALVAC-HIV Placebo
1 ml per injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must have participated in RV144, received the active product, and completed all 4 vaccination visits per protocol.
  2. Must be able to read and willing to complete the informed consent process.
  3. Must successfully complete a Test of Understanding (TOU) prior to enrollment. The volunteer must answer 80% or 8 out of 10 of the questions correctly including two compulsory questions answered correctly. If the volunteer is unable to do so, he or she will be given two more opportunities to repeat the TOU. If after three attempts to pass the TOU the volunteer is still unable to do so, the volunteer will become ineligible for study participation.
  4. Must be in good general health without clinically significant medical history.
  5. HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
  6. Laboratory screening analysis:

    • Hemoglobin: Women ≥12.0 mg/dL, Men ≥12.5 mg/dL
    • White cell count: 4,000 to 11,000 cells/mm3
    • Platelets: 150,000 to 450,000/mm3
    • Normal liver function: ALT/AST ≤1.25 institutional upper limit of reference range
    • Creatinine: ≤1.25 institutional upper limit of reference range
  7. Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
  8. Female-Specific Criteria:

    • Negative human choriogonadotropin (β-HCG) pregnancy test (urine) for women prior each vaccination (same day).
    • Be using adequate birth control methods for 45 days prior to the first vaccine/placebo vaccination and will continue to be followed 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), abstinence.

Exclusion Criteria:

  1. 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.
  2. History of anaphylaxis or other serious adverse reaction to vaccines, including to RV144 vaccines, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including eggs, egg products, streptomycin, or neomycin.
  3. Subject has received any of the following substances:

    • Chronic use of therapies which may modify immune response, such as IV immune globulin 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 14 days prior to HIV screening.
    • Any vaccine within 14 days prior to initial study vaccine administration in the present study.
    • Receipt of any investigational HIV vaccine other that the RV 144 regimen.
    • Investigational research agents within 30 days prior to initial study vaccine administration in the present study.
    • Use of anti-tuberculosis prophylaxis or therapy during the past 90 days.
  4. 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.
  5. 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 plan or attempt.
  6. Study site employees who are involved in the protocol and/or may have direct access to study related area.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435135

Locations
Thailand
Bang Lamung District Hospital
Chon Buri, Thailand
Phan Thong District Hospital
Chon Buri, Thailand
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Supachai Rerks-Ngarm, MD Department of Disease Control, Ministry of Public Health
  More Information

Publications:
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01435135     History of Changes
Other Study ID Numbers: RV 305, WRAIR #1792, A-14430.13, S-10-0010
Study First Received: September 8, 2011
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
Thailand: Ministry of Public Health
Thailand: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014