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Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931358
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Tracking Information
First Submitted Date  ICMJE August 12, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE September 24, 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • Change in Immune Response [ Time Frame: Through Week 96 ]
    Characterization of vaccine-induced immune responses in the systemic and mucosal compartments by intracellular cytokine staining (ICS) and IFN-gamma ELISPOT at Baseline, Weeks 4, 12, 14, 24, 26, 36, 48, 50, 72 and 96.
  • Change in Humoral Immune Response [ Time Frame: Through Week 96 ]
    Characterization of vaccine-induced humoral immune response in the systemic and mucosal compartments by binding and neutralizing antibodies at Baseline, Weeks 4, 12, 14, 24, 26, 36, 48, 50, 72 and 96.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
Safety Monitoring [ Time Frame: Through Week 48 ]
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling and limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards during the 3 days post-vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Biological: ALVAC-HIV
    1 mL intramuscular injection containing 10^6 CCID50/dose
  • 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
Study Arms  ICMJE
  • Experimental: Group Ia
    ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
    Interventions:
    • Biological: ALVAC-HIV
    • Biological: AIDSVAX B/E
  • Placebo Comparator: Group Ib
    ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
    Interventions:
    • Biological: ALVAC-HIV Placebo
    • Biological: AIDSVAX B/E Placebo
  • Experimental: Group IIa
    ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48
    Interventions:
    • Biological: ALVAC-HIV
    • Biological: AIDSVAX B/E
  • Placebo Comparator: Group IIb
    ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12, 24 and 48
    Interventions:
    • Biological: ALVAC-HIV Placebo
    • Biological: AIDSVAX B/E Placebo
  • Experimental: Group IIIa
    ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24; AIDSVAX B/E at Week 48
    Interventions:
    • Biological: ALVAC-HIV
    • Biological: AIDSVAX B/E
  • Placebo Comparator: Group IIIb
    ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24; AIDSVAX B/E Placebo at Week 48
    Interventions:
    • Biological: ALVAC-HIV Placebo
    • Biological: AIDSVAX B/E Placebo
  • Experimental: Group IVa
    ALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
    Interventions:
    • Biological: ALVAC-HIV
    • Biological: AIDSVAX B/E
  • Placebo Comparator: Group IVb
    ALVAC-HIV Placebo at Weeks 0, 4 and 48; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
    Interventions:
    • Biological: ALVAC-HIV Placebo
    • Biological: AIDSVAX B/E Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2013)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931358
Other Study ID Numbers  ICMJE RV 306
WRAIR 1920 ( Other Identifier: WRAIR IRB )
S-11-0002 ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party U.S. Army Medical Research and Development Command
Study Sponsor  ICMJE U.S. Army Medical Research and Development Command
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Punnee Pitisuttithum, MD, DTM&H Mahidol University
PRS Account U.S. Army Medical Research and Development Command
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP