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HIV InfectionsPhase 2NCT01931358

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

A Phase 2 study testing ALVAC-HIV and AIDSVAX B/E in people with HIV Infections, run by U.S. Army Medical Research and Development Command at 3 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
ALVAC-HIV and AIDSVAX B/E
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
3 sitesThailand
Study dates
24 Sep 2013to Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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:
  • 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.

Who cannot join

  • 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:
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  • 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.
  • 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.
  • Study site employees who are involved in the protocol and/or may have direct access to study related area.

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

  • Royal Thai Army Clinical Research Center, AFRIMS

    Bangkok, 10400

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

    Bangkok, 10400

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

    Chiang Mai, 50202

Other trials in Thailand

About this study

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

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.

Conditions
HIV Infections
Being tested
ALVAC-HIV, AIDSVAX B/E, ALVAC-HIV Placebo, AIDSVAX B/E Placebo
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALVAC-HIVBiological

    1 mL intramuscular injection containing 10^6 CCID50/dose

  • AIDSVAX B/EBiological

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

  • ALVAC-HIV PlaceboBiological

    1 mL per injection

  • AIDSVAX B/E PlaceboBiological

    1 mL per injection

Study groups in NCT01931358
Study groupRoleWhat they receive
Group IaExperimentalALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Receives: Biological: ALVAC-HIV; Biological: AIDSVAX B/E
Group IbPlacebo comparatorALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
Receives: Biological: ALVAC-HIV Placebo; Biological: AIDSVAX B/E Placebo
Group IIaExperimentalALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48
Receives: Biological: ALVAC-HIV; Biological: AIDSVAX B/E
Group IIbPlacebo comparatorALVAC-HIV Placebo at Weeks 0 and 4; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12, 24 and 48
Receives: Biological: ALVAC-HIV Placebo; Biological: AIDSVAX B/E Placebo
Group IIIaExperimentalALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24; AIDSVAX B/E at Week 48
Receives: Biological: ALVAC-HIV; Biological: AIDSVAX B/E
Group IIIbPlacebo comparatorALVAC-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
Receives: Biological: ALVAC-HIV Placebo; Biological: AIDSVAX B/E Placebo
Group IVaExperimentalALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Receives: Biological: ALVAC-HIV; Biological: AIDSVAX B/E
Group IVbPlacebo comparatorALVAC-HIV Placebo at Weeks 0, 4 and 48; ALVAC-HIV Placebo + AIDSVAX B/E Placebo at Weeks 12 and 24
Receives: Biological: ALVAC-HIV Placebo; Biological: AIDSVAX B/E Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through Week 96

  2. 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.

    Measured: Through Week 96

Secondary outcomes (1)

  1. Safety Monitoring

    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.

    Measured: Through Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study start24 Sep 2013
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931358
Sponsor's protocol ID
RV 306
Other IDs
WRAIR 1920, S-11-0002
Status last verified
Mar 2021
First submitted
12 Aug 2013
Last updated
26 Mar 2021
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19843557

  • 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.

    PubMed 22837492

  • 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.

    PubMed 37260254

  • 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.

    PubMed 32035516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALVAC-HIV and AIDSVAX B/E in people with HIV Infections, run by U.S. Army Medical Research and Development Command at 3 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Immune Response (time frame: Through Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01931358, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.

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