Perturbing of HIV Reservoir With Immune Stimulation

NCT02707692 | Completed Results

• 2 other identifiers: 1600891R01AI118422-01A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines on the HIV transcriptional activity in individuals who are virologically suppressed for at least 48 weeks on similar ART. The proposed study is a randomized double-blinded control trial conducted over 28 weeks. Randomized interventions will be injections of Influenza vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but in a randomized order.

Conditions

AIDS; HIV

Keywords

HIV; AIDS; Immune Stimulation; HIV Reservoir

Outcome Measures

Primary Outcomes (1)

• Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7

  CD4+ T cell-associated HIV RNA was measured before vaccination on Day 0 and again on Day 7. The Day-0 measure of CD4+ T cell-associated HIV RNA transcription was subtracted from the Day-7 measure.

  Day 0 and Day 7

Study Arms (6)

Pneumococcal, then Influenza, then Placebo vaccination

OTHER

Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Pneumococcal, then Placebo, then Influenza vaccination

OTHER

Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Influenza, then Pneumococcal, then Placebo vaccination

OTHER

Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Influenza, then Placebo, then Pneumococcal vaccination

OTHER

Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Placebo, then Pneumococcal, then Influenza vaccination

OTHER

Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Placebo, then Influenza, then Pneumococcal vaccination

OTHER

Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).

Biological: Fluarix; Biological: Pneumovax; Other: Placebo

Interventions

Fluarix BIOLOGICAL

Intramuscular injection with Fluarix® .

Influenza, then Placebo, then Pneumococcal vaccination; Influenza, then Pneumococcal, then Placebo vaccination; Placebo, then Influenza, then Pneumococcal vaccination; Placebo, then Pneumococcal, then Influenza vaccination; Pneumococcal, then Influenza, then Placebo vaccination; Pneumococcal, then Placebo, then Influenza vaccination

Pneumovax BIOLOGICAL

Intramuscular injection with Pneumovax.

Influenza, then Placebo, then Pneumococcal vaccination; Influenza, then Pneumococcal, then Placebo vaccination; Placebo, then Influenza, then Pneumococcal vaccination; Placebo, then Pneumococcal, then Influenza vaccination; Pneumococcal, then Influenza, then Placebo vaccination; Pneumococcal, then Placebo, then Influenza vaccination

Placebo OTHER

Intramuscular injection with sterile saline (placebo).

Influenza, then Placebo, then Pneumococcal vaccination; Influenza, then Pneumococcal, then Placebo vaccination; Placebo, then Influenza, then Pneumococcal vaccination; Placebo, then Pneumococcal, then Influenza vaccination; Pneumococcal, then Influenza, then Placebo vaccination; Pneumococcal, then Placebo, then Influenza vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV-1 infection more than 365 days ago (HIV antibody or viral load positive).
• Capable of signing written informed consent.
• Documented viral s suppression for at least 48 weeks (≤50 copies/mL)
• Men and women between 18 and 65 years of age.
• Read and comprehend English.
• Documented CD4 count at enrollment (\>250 cells/µl)
• Reported CD4 nadir \>100 cells/µl.
• Received seasonal flu vaccination at least 6 weeks prior to first trial injection (and not more recently)
• Received vaccination for pneumococcal disease at least 12 months prior to first trial injection (and not more recently)
• Started ART during chronic infection (\> 6 months from estimated date of injection)

You may not qualify if:

• Uncontrolled psychiatric condition.
• Under the influence of drug(s) or alcohol at time of screening.
• Any condition that, in the opinion of the investigator, would limit follow-up and adequate consent.
• History of allergic reactions to any of the proposed vaccines or egg allergy.
• History of Gullian Barre syndrome
• Receiving immunosuppressive medications.
• Pregnancy or lactation.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

UCSD Antiviral Research Center (AVRC)

San Diego, California, 92103-8208, United States

Location

Related Publications (1)

• Gianella S, Anderson C, Chaillon A, Wells A, Porrachia M, Caballero G, Meneses M, Lonergan J, Woodworth B, Gaitan NC, Rawlings SA, Muttera L, Harkness L, Little SJ, May S, Smith D. Impact of influenza and pneumococcal vaccines on HIV persistence and immune dynamics during suppressive antiretroviral therapy. AIDS. 2024 Jul 1;38(8):1131-1140. doi: 10.1097/QAD.0000000000003882. Epub 2024 Mar 22.

  PMID: 38526550 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

fluarix; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: David (Davey) Smith
• Organization: UC San Diego

d13smith@health.ucsd.edu

619-300-9638

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 14, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: January 1, 2022
• Last Updated: August 24, 2022
• Results First Posted: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)