AIDSNCT02707692

Perturbing of HIV Reservoir With Immune Stimulation

A study testing Fluarix and Pneumovax in people with AIDS and HIV, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: AIDS, HIV
What is being tested?: Fluarix and Pneumovax
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 10Show fewer

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSD Antiviral Research Center (AVRC)
San Diego, California, 92103-8208

Other trials in United States

About this study

Official title: Perturbing the HIV Reservoir With Immune Stimulation

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.

Read the detailed description

Title: Perturbing the HIV Reservoir

Sample Size: 56

Study Population: HIV-infected individuals between 18 and 65 years old who started similar antiretroviral therapy (ART) during chronic infection and remained virally suppressed for at least 48 weeks before enrollment. Participants will have CD4 >250 cells/μl at enrollment and a CD4 nadir >100 cells/μl.

Participating Sites: UCSD's Antiviral Research Center (AVRC)

Study Design: 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.

Schedule of Evaluations: Study evaluations will be based on three 30 day cycles (Influenza vaccine, Pneumococcus vaccine, Placebo in random order) over 28 weeks of the RCT. Pre injection: one paired blood and genital secretion sample will be collected before each injection. Post-injection: paired blood and genital secretion samples will be collected on days 2, 4, 7, 14 and 30 after each injection.

Study Duration: 240 weeks

Study Regimen/Intervention: This is a double blind RCT of two vaccines (Pneumovax®23 and Fluarix®) plus placebo (sterile saline injection). Study participants will be followed for 28 weeks after enrollment. During this 28-week period, blood and genital secretion samples will be collected on day 0 and five subsequent time points after each injection (days 2, 4, 7, 14 and 30). Injections (vaccine or placebo) will be administered 12 weeks apart and in a random order, to minimize a possible bias due to the order of the vaccines.

Primary Objective: 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.

Primary Outcome: Average level of CD4+ T cell-associated HIV RNA transcription measured at days 2, 4, 7, 14 and 30 after each injection.

Conditions: AIDS, HIV
Being tested: Fluarix, Pneumovax, Placebo
Keywords: HIV, AIDS, Immune Stimulation, HIV Reservoir
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

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

FluarixBiological
Intramuscular injection with Fluarix® .
PneumovaxBiological
Intramuscular injection with Pneumovax.
PlaceboOther
Intramuscular injection with sterile saline (placebo).

Study groups in NCT02707692
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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®). Receives: 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). Receives: 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®). Receives: Biological: Fluarix; Biological: Pneumovax; Other: Placebo

What is being measured

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

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.
Measured: Day 0 and Day 7

Timeline

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

Aug 2016Jan 2022

First posted14 Mar 2016 (estimated)
Study startAug 2016
Primary completionApr 2020
Study completionJan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AIDSStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02707692
Sponsor's protocol ID: 160089
Other IDs: 1R01AI118422-01A1
Status last verified: Aug 2022
First submitted: 23 Feb 2016
Last updated: 24 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 38526550

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perturbing the HIV Reservoir With Immune Stimulation
ClinicalTrials.gov ID: NCT02707692
Acronym / sponsor ID: 160089
Conditions: AIDS, HIV
Keywords: HIV, AIDS, Immune Stimulation, HIV Reservoir
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Aug 2016 (actual)
Primary completion: Apr 2020 (actual)
Study completion: Jan 2022 (actual)
First posted: 14 Mar 2016 (estimated)
Results: Posted 24 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Title: Perturbing the HIV Reservoir

Sample Size: 56

Participating Sites: UCSD's Antiviral Research Center (AVRC)

Study Duration: 240 weeks

Primary Outcome: Average level of CD4+ T cell-associated HIV RNA transcription measured at days 2, 4, 7, 14 and 30 after each injection.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Pneumococcal, then Influenza, then Placebo vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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).
Pneumococcal, then Placebo, then Influenza vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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).
Influenza, then Pneumococcal, then Placebo vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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).
Influenza, then Placebo, then Pneumococcal vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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®).
Placebo, then Pneumococcal, then Influenza vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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).
Placebo, then Influenza, then Pneumococcal vaccination	Other	Biological: Fluarix, Biological: Pneumovax, Other: PlaceboParticipants 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®).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluarixIntramuscular injection with Fluarix® .	Biological	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
PneumovaxIntramuscular injection with Pneumovax.	Biological	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
PlaceboIntramuscular injection with sterile saline (placebo).	Other	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

Primary outcome

Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
Time frame: Day 0 and 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.

Results and safety

Results posted to the registry on 24 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pneumococcal, Then Influenza, Then Placebo Vaccination	9	8
Pneumococcal, Then Placebo, Then Influenza Vaccination	9	6
Influenza, Then Pneumococcal, Then Placebo Vaccination	9	8
Influenza, Then Placebo, Then Pneumococcal Vaccination	9	9
Placebo, Then Pneumococcal, Then Influenza Vaccination	9	8
Placebo, Then Influenza, Then Pneumococcal Vaccination	9	8

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

Time frame: Day 0 and Day 7. Mean (Standard Deviation). Unit: HIV RNA copies per million cell

Measure	Pneumococcal Vaccine n = 42	Influenza Vaccine n = 44	Placebo n = 45
Value	-471.8 (2998.0)	-45.9 (243.2)	332.3 (2266.4)

Pneumococcal Vaccine vs Placebo: Mean Difference (Final Values): -988.0 (95% CI -2996.3 to 1020.3), p = 0.32, Paired t-test, 2 sided
Influenza Vaccine vs Placebo: Mean Difference (Final Values): -405.0 (95% CI -1199.7 to 389.7), p = 0.31, Paired t-test, 2 sided

Population analysed: Within each cycle, all participants who received the vaccination and completed the Day-7 visit were included in the analysis.

Adverse events

Time frame: From baseline until the end of Cycle 3 (up to 417 days on study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pneumococal Vaccine	1 of 45 (2.2%)	0 of 45 (0%)	0 of 45
Influenza Vaccine	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Placebo	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38526550Gianella 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fluarix and Pneumovax in people with AIDS and HIV, run by University of California, San Diego at 1 site in United States.

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 10 inclusion and 7 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: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7 (time frame: Day 0 and Day 7). 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 NCT02707692, which also lists 1 linked publication.

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 24 Aug 2022.