NCT01931358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

September 24, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

8.2 years

First QC Date

August 12, 2013

Last Update Submit

March 25, 2021

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

  • Change in Immune Response

    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.

    Through Week 96

  • Change in Humoral Immune Response

    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.

    Through Week 96

Secondary Outcomes (1)

  • Safety Monitoring

    Through Week 48

Study Arms (8)

Group Ia

EXPERIMENTAL

ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24

Biological: ALVAC-HIVBiological: AIDSVAX B/E

Group Ib

PLACEBO COMPARATOR

ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24

Biological: ALVAC-HIV PlaceboBiological: AIDSVAX B/E Placebo

Group IIa

EXPERIMENTAL

ALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48

Biological: ALVAC-HIVBiological: AIDSVAX B/E

Group IIb

PLACEBO COMPARATOR

ALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12, 24 and 48

Biological: ALVAC-HIV PlaceboBiological: AIDSVAX B/E Placebo

Group IIIa

EXPERIMENTAL

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-HIVBiological: AIDSVAX B/E

Group IIIb

PLACEBO COMPARATOR

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 PlaceboBiological: AIDSVAX B/E Placebo

Group IVa

EXPERIMENTAL

ALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24

Biological: ALVAC-HIVBiological: AIDSVAX B/E

Group IVb

PLACEBO COMPARATOR

ALVAC-HIV Placebo at Weeks 0, 4 and 48; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24

Biological: ALVAC-HIV PlaceboBiological: AIDSVAX B/E Placebo

Interventions

ALVAC-HIVBIOLOGICAL

1 mL intramuscular injection containing 10\^6 CCID50/dose

Group IIIaGroup IIaGroup IVaGroup Ia
AIDSVAX B/EBIOLOGICAL

1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)

Group IIIaGroup IIaGroup IVaGroup Ia
ALVAC-HIV PlaceboBIOLOGICAL

1 mL per injection

Group IIIbGroup IIbGroup IVbGroup Ib
AIDSVAX B/E PlaceboBIOLOGICAL

1 mL per injection

Group IIIbGroup IIbGroup IVbGroup Ib

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Must be at low risk for HIV infection per investigator assessment.
  • Must be able to understand and complete the informed consent process.
  • Must be capable of reading Thai.
  • Must successfully complete a Test of Understanding prior to enrollment.
  • Must be in good general health without clinically significant medical history.
  • HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
  • 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.
  • Female-Specific Criteria:
  • +2 more criteria

You may not qualify if:

  • Asplenia: any condition resulting in the absence of a functional spleen.
  • Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
  • Therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international normalized ration (INR) of partial prothrombin time (PTT).
  • 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.
  • 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.
  • 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.
  • Active sexually transmitted infection confirmed by clinical exam and diagnostic test.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Thai Army Clinical Research Center, AFRIMS

Bangkok, 10400, Thailand

Location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

Research Institute for Health Sciences (RIHES), Chiang Mai University

Chiang Mai, 50202, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 19843557BACKGROUND

  • 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.

    PMID: 22837492BACKGROUND

  • Shubin Z, Stanfield-Oakley S, Puangkaew J, Pitisutthithum P, Nitayaphan S, Gurunathan S, Sinangil F, Chariyalertsak S, Phanuphak N, Ake JA, O'Connell RJ, Vasan S, Akapirat S, Eller MA, Ferrari G, Paquin-Proulx D; for the RV306 Study Group. Additional boosting to the RV144 vaccine regimen increased Fc-mediated effector function magnitude but not durability. AIDS. 2023 Aug 1;37(10):1519-1524. doi: 10.1097/QAD.0000000000003611. Epub 2023 Jun 1.

    PMID: 37260254DERIVED

  • Pitisuttithum P, Nitayaphan S, Chariyalertsak S, Kaewkungwal J, Dawson P, Dhitavat J, Phonrat B, Akapirat S, Karasavvas N, Wieczorek L, Polonis V, Eller MA, Pegu P, Kim D, Schuetz A, Jongrakthaitae S, Zhou Y, Sinangil F, Phogat S, Diazgranados CA, Tartaglia J, Heger E, Smith K, Michael NL, Excler JL, Robb ML, Kim JH, O'Connell RJ, Vasan S; RV306 study group. Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e238-e248. doi: 10.1016/S2352-3018(19)30406-0. Epub 2020 Feb 6.

    PMID: 32035516DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

AIDSVAXAIDSVAX B-E

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Punnee Pitisuttithum, MD, DTM&H

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 29, 2013

Study Start

September 24, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

TH(3)