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

NCT ID: NCT01435135

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2021-07-31

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group I

ALVAC-HIV + AIDSVAX B/E or ALVAC-HIV placebo + AIDSVAX B/E placebo at Weeks 0 and 24

Group Type: EXPERIMENTAL

ALVAC-HIV

Intervention Type: BIOLOGICAL

1 mL per injection containing 10\^6 CCID50/dose administered

AIDSVAX B/E

Intervention Type: BIOLOGICAL

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

ALVAC-HIV Placebo

Intervention Type: BIOLOGICAL

1 ml per injection

AIDSVAX B/E Placebo

Intervention Type: BIOLOGICAL

1 ml per injection

Group II

AIDSVAX B/E or AIDSVAX B/E placebo at Weeks 0 and 24

Group Type: EXPERIMENTAL

AIDSVAX B/E

Intervention Type: BIOLOGICAL

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

AIDSVAX B/E Placebo

Intervention Type: BIOLOGICAL

1 ml per injection

Group III

ALVAC-HIV or ALVAC-HIV placebo at Weeks 0 and 24

Group Type: EXPERIMENTAL

ALVAC-HIV

Intervention Type: BIOLOGICAL

1 mL per injection containing 10\^6 CCID50/dose administered

ALVAC-HIV Placebo

Intervention Type: BIOLOGICAL

1 ml per injection

Interventions

ALVAC-HIV

1 mL per injection containing 10\^6 CCID50/dose administered

Intervention Type: BIOLOGICAL

AIDSVAX B/E

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

Intervention Type: BIOLOGICAL

ALVAC-HIV Placebo

1 ml per injection

Intervention Type: BIOLOGICAL

AIDSVAX B/E Placebo

1 ml per injection

Intervention Type: BIOLOGICAL

Other Intervention Names

(vCP1521)

Eligibility Criteria

Inclusion Criteria

• Must have participated in RV144, received the active product, and completed all 4 vaccination visits per protocol.
• Must be able to understand and complete the informed consent process.
• Must successfully complete a Test of Understanding 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.
• Must be in good general health without clinically significant medical history.
• HIV-uninfected per predefined 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/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
• Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
• Female-Specific Criteria:

• Negative human choriogonadotropin (β-HCG) pregnancy test (urine) for women prior to 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.

• History of anaphylaxis or other serious adverse reaction to vaccines including to RV 144 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 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 nonchronic 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 investigational HIV vaccine product other than 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.
• Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication 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 plan or attempt.
• Study site employees who are involved in the protocol and/or may have direct access to study related area.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Supachai Rerks-Ngarm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand

Locations

Bang Lamung District Hospital

Chon Buri, , Thailand

Phan Thong District Hospital

Chon Buri, , Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 19843557 (View on PubMed)

Williams LD, Shen X, Sawant SS, Akapirat S, Dahora LC, Tay MZ, Stanfield-Oakley S, Wills S, Goodman D, Tenney D, Spreng RL, Zhang L, Yates NL, Montefiori DC, Eller MA, Easterhoff D, Hope TJ, Rerks-Ngarm S, Pittisuttithum P, Nitayaphan S, Excler JL, Kim JH, Michael NL, Robb ML, O'Connell RJ, Karasavvas N, Vasan S, Ferrari G, Tomaras GD; RV305 study team. Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response. PLoS Pathog. 2023 May 31;19(5):e1011359. doi: 10.1371/journal.ppat.1011359. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37256916 (View on PubMed)

Rerks-Ngarm S, Pitisuttithum P, Excler JL, Nitayaphan S, Kaewkungwal J, Premsri N, Kunasol P, Karasavvas N, Schuetz A, Ngauy V, Sinangil F, Dawson P, deCamp AC, Phogat S, Garunathan S, Tartaglia J, DiazGranados C, Ratto-Kim S, Pegu P, Eller M, Karnasuta C, Montefiori DC, Sawant S, Vandergrift N, Wills S, Tomaras GD, Robb ML, Michael NL, Kim JH, Vasan S, O'Connell RJ; RV305 Study Team. Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial. J Infect Dis. 2017 Apr 15;215(8):1255-1263. doi: 10.1093/infdis/jix099.

Reference Type: DERIVED

PMID: 28329190 (View on PubMed)

Easterhoff D, Moody MA, Fera D, Cheng H, Ackerman M, Wiehe K, Saunders KO, Pollara J, Vandergrift N, Parks R, Kim J, Michael NL, O'Connell RJ, Excler JL, Robb ML, Vasan S, Rerks-Ngarm S, Kaewkungwal J, Pitisuttithum P, Nitayaphan S, Sinangil F, Tartaglia J, Phogat S, Kepler TB, Alam SM, Liao HX, Ferrari G, Seaman MS, Montefiori DC, Tomaras GD, Harrison SC, Haynes BF. Boosting of HIV envelope CD4 binding site antibodies with long variable heavy third complementarity determining region in the randomized double blind RV305 HIV-1 vaccine trial. PLoS Pathog. 2017 Feb 24;13(2):e1006182. doi: 10.1371/journal.ppat.1006182. eCollection 2017 Feb.

Reference Type: DERIVED

PMID: 28235027 (View on PubMed)

Other Identifiers

WRAIR #1792

Identifier Type: OTHER

Identifier Source: secondary_id

A-14430.13

Identifier Type: OTHER

Identifier Source: secondary_id

S-10-0010

Identifier Type: OTHER

Identifier Source: secondary_id

RV 305

Identifier Type: -

Identifier Source: org_study_id