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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by U.S. Army Medical Research and Materiel Command
Sponsor:
Collaborator:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01931358
First received: August 12, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


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: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Immune Response [ Time Frame: Through Week 96 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety Monitoring [ Time Frame: Through Week 48 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 360
Study Start Date: September 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Ia
ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
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)
Placebo Comparator: Group Ib
ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
Biological: ALVAC-HIV Placebo
1 mL per injection
Biological: AIDSVAX B/E Placebo
1 mL per injection
Experimental: Group IIa
ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48
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)
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
Biological: ALVAC-HIV Placebo
1 mL per injection
Biological: AIDSVAX B/E Placebo
1 mL per injection
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
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)
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
Biological: ALVAC-HIV Placebo
1 mL per injection
Biological: AIDSVAX B/E Placebo
1 mL per injection
Experimental: Group IVa
ALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
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)
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
Biological: ALVAC-HIV Placebo
1 mL per injection
Biological: AIDSVAX B/E Placebo
1 mL per injection

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01931358

Contacts
Contact: Punnee Pitisuttithum, MD, DTM&H 66 8 1829 4906 punnee.pit@mahidol.ac.th

Locations
Thailand
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University Recruiting
Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum,, MD, DTM&H    +66 8 1829 4906    punnee.pit@mahidol.ac.th   
Principal Investigator: Punnee Pitisuttithum, MD, DTM&H         
Sub-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         
Royal Thai Army Clinical Research Center, AFRIMS Recruiting
Bangkok, Thailand, 10400
Contact: Narongrid Sirisopana, MD    +66-81-908-6888    NarongridS@afrims.org   
Principal Investigator: Sorachi Nitayaphan, MD, PhD         
Sub-Investigator: Jintanat Ananworanich, MD, PhD         
Sub-Investigator: Narongrid Sirisopana, MD         
Research Institute for Health Sciences (RIHES), Chiang Mai University Recruiting
Chiang Mai, Thailand, 50202
Contact: Suwat Chariyalertsak, MD, DrPH    +66 850 404 524    schariya@med.cmu.ac.th   
Principal Investigator: Suwat Chariyalertsak, MD, DrPH         
Sub-Investigator: Natthapol Kosashunhanan, MD         
Sub-Investigator: Nuntisa Chotirosniramit, MD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Punnee Pitisuttithum, MD, DTM&H Mahidol University
  More Information

Publications:
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01931358     History of Changes
Other Study ID Numbers: RV 306, WRAIR 1920, S-11-0002
Study First Received: August 12, 2013
Last Updated: July 14, 2014
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 September 22, 2014