HIV InfectionPhase 2VIP-H1N1NCT01155037

Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults

A Phase 2 study testing Adjuvanted vaccine against H1N1 influenza virus (GSK) in people with HIV Infection, run by Oswaldo Cruz Foundation at 1 site in Brazil.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infection
What is being tested?: Adjuvanted vaccine against H1N1 influenza virus (GSK)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteBrazil
Study dates: Mar 2010to Apr 2012
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 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Both genders, aged between 18 and 59 years;
Capacity to give informed consent voluntarily to participate in the study;
Study participants with reproductive potential (defined as girls after menarche or women who have not reached menopause at least during 24 consecutive months, or who menstruated during the past 24 months, or have not undergone surgical sterilization) must have pregnancy test negative results, in blood or urine, at screening and in the vaccine application days. If they have sexual practices likely to promote pregnancy, the participants must use some form of contraception during the study period. At least one of the following methods MUST be properly used: Condoms (male or female, Hormonal contraceptive.
Laboratory results in the study screening: hemoglobin > 8.0 g/dL; Direct bilirubin < 2.5 x the upper limit of normal; Alanine aminotransferase, ALT (SGPT) and aspartate aminotransferase, AST (SGOT) < 3 x the upper limit of normal; Platelet count > 100.000/mm3
Inclusion Criteria - unique to the participants with HIV infection:
HIV-1 infection (as evidenced by rapid HIV testing or ELISA kit approved and confirmed by repeating the ELISA, IFA, Western blot, HIV-1 plasma viral load) at any time before entering the study.

Show all 11Show fewer

Without changing the antiretroviral treatment within 8 weeks prior to the screening for the study: If the volunteer is receiving HAART he/she is required to be using the same regimen within at least 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (eg. the conventional formulation for combination formulations) is allowed. If the volunteer is not on regular antiretroviral treatment, he/she should not have received any dose of any antiretroviral within 8 weeks prior to screening, including for the prevention of HIV vertical transmission (previous prophylactic and therapeutic regimens are allowed)
Without planning to change or start HAART in the next 6 months.
Inclusion criteria - unique to the participants without HIV infection (control group):
HIV-negative test result documented by rapid test approved in Brazil
Health professionals with indication of receiving H1N1 virus vaccine

Who cannot join

Use of any systemic anticancer or immunomodulator treatment, corticosteroid, experimental vaccines, interleukins, interferons, growth factors or intravenous immunoglobulin (IVIG) within 45 days prior to entry into the study.
Pregnancy or lactation.
Allergy and/or sensitivity or any known hypersensitivity to residues present in the vaccine (egg, chicken protein, egg albumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) and/or thimerosal.
Use of alcohol or addiction or other conditions which in the opinion of the site's investigator, may interfere with compliance to the study requirements.
D5. Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry into the study
Severe febrile illness or acute infection at the time of screening for the study and/or days of vaccination

Show all 11Show fewer

Vaccination against seasonal influenza in the last 12 months prior to study entry
Previous vaccination against influenza A H1N1
History or family history of Guillain-Barré Syndrome (parents, siblings, half-siblings or children).
Diagnosis of neurological condition including (but not limited to) the absence of deep tendon reflexes, Achilles and patellar, in both legs (four missing) in the last six months.
Disproportionate force loss in lower limb(s) compared to the upper limbs in the last six months.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro

Other trials in Brazil

About this study

Official title: Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted A(H1N1)v Influenza Vaccine in HIV-Infected Adults

This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals, in which each of the randomized groups will be compared with HIV-negative volunteers vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be included in the study HIV-infected patients, stratified by CD4 count (< 200 cells/mm3 or > 200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy treatment or receiving stable treatment for at least 8 weeks, with no plans to change over the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group will be formed by HIV-negative individuals, confirmed by serology performed at screening, eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2) 7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine against the H1N1 virus promotes antibody titers above the level specified for protection (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of the vaccine against H1N1 virus is similar to the proportion after the second dose.

Conditions: HIV Infection
Being tested: Adjuvanted vaccine against H1N1 influenza virus (GSK)
Keywords: HIV, influenza A H1N1, vaccine
Medical subject headings: HIV Infections, Orthomyxoviridae Infections

What participants receive

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

Adjuvanted vaccine against H1N1 influenza virus (GSK)Biological
Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
Adjuvanted vaccine against H1N1 influenza virus (GSK)Biological
Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
Adjuvanted vaccine against H1N1 influenza virus (GSK)Biological
Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.

Study groups in NCT01155037
Study group	Role	What they receive
3.75 µg of the vaccine on days 0 and 21	Experimental	Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart. Receives: Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
7.5 µg of the vaccine on days 0 and 21	Experimental	Patients infected with HIV will receive 7.5µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart. Receives: Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)
3.75 µg of the vaccine on day 0	Active comparator	The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine. Receives: Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)

What is being measured

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

proportions of seroconversion
proportions of seroconversion for influenza A H1N1 in each of the four subsets of HIV-positive patients, and in the control group
Measured: 21 days after vaccination regimen
proportions of seroprotection
proportions of seroprotection for influenza A H1N1 in each of the four subsets of HIV-positive patients and in the control group
Measured: 21 days after vaccination regimen
Safety of the A H1N1 vaccine at two different regimens in HIV-infected adults
Safety and tolerability of the vaccine against H1N1 virus in different doses and administration regimens in IV-infected adults
Measured: 1 months after vaccination

Secondary outcomes (4)

Prevalence of A H1N1 influenza symptomatic disease in the study population
proportions of the vaccine's protective factor against influenza A H1N1 in each of the four subsets of HIV-positive patients and in the control group
Measured: 12 months after vaccination
Persistence of antibodies against H1N1 virus
Evaluate the persistence of antibody titers against H1N1 virus after the vaccine series in HIV-infected patients and control group
Measured: 12 months after vaccination
Changes in HIV viral load and CD4
Assess changes in HIV-1 viral load and CD4+ counts after the vaccine series.
Measured: 12 months after vaccination
Cellular immune responses to H1N1 vaccination in HIV-infected patients
Determine the cellular immune responses and their correlation to the development and magnitude of responses to H1N1 virus, and compare the cellular immune responses
Measured: 12 months after vaccination

Timeline

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

Mar 2010Apr 2012

First posted1 Jul 2010 (estimated)
Study startMar 2010
Primary completionMar 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01155037
Sponsor's protocol ID: VIP-H1N1
Acronym: VIP-H1N1
Status last verified: Jul 2018
First submitted: 29 Jun 2010
Last updated: 18 Jul 2018
Results posted: No
Data monitoring committee: No

Publications

Santini-Oliveira M, Camacho LA, Souza TM, Luz PM, Vasconcellos MT, Giacoia-Gripp CB, Morgado MG, Nunes EP, Lemos AS, Ferreira AC, Moreira RI, Veloso VG, Siqueira MM, Grinsztejn B. H1N1pdm09 adjuvanted vaccination in HIV-infected adults: a randomized trial of two single versus two double doses. PLoS One. 2012;7(6):e39310. doi: 10.1371/journal.pone.0039310. Epub 2012 Jun 25.
PubMed 22761759

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?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted A(H1N1)v Influenza Vaccine in HIV-Infected Adults
ClinicalTrials.gov ID: NCT01155037
Acronym / sponsor ID: VIP-H1N1 / VIP-H1N1
Conditions: HIV Infection
Keywords: HIV, influenza A H1N1, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Oswaldo Cruz FoundationUniversity, hospital or other
Collaborators: Ministry of Health, Brazil
Study start: Mar 2010
Primary completion: Mar 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 1 Jul 2010 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
3.75 µg of the vaccine on days 0 and 21	Experimental	Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
7.5 µg of the vaccine on days 0 and 21	Experimental	Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)Patients infected with HIV will receive 7.5µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
3.75 µg of the vaccine on day 0	Active comparator	Biological: Adjuvanted vaccine against H1N1 influenza virus (GSK)The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Both genders, aged between 18 and 59 years;
Capacity to give informed consent voluntarily to participate in the study;
Study participants with reproductive potential (defined as girls after menarche or women who have not reached menopause at least during 24 consecutive months, or who menstruated during the past 24 months, or have not undergone surgical sterilization) must have pregnancy test negative results, in blood or urine, at screening and in the vaccine application days. If they have sexual practices likely to promote pregnancy, the participants must use some form of contraception during the study period. At least one of the following methods MUST be properly used: Condoms (male or female, Hormonal contraceptive.
Laboratory results in the study screening: hemoglobin > 8.0 g/dL; Direct bilirubin < 2.5 x the upper limit of normal; Alanine aminotransferase, ALT (SGPT) and aspartate aminotransferase, AST (SGOT) < 3 x the upper limit of normal; Platelet count > 100.000/mm3
HIV-1 infection (as evidenced by rapid HIV testing or ELISA kit approved and confirmed by repeating the ELISA, IFA, Western blot, HIV-1 plasma viral load) at any time before entering the study.

Key exclusion criteria (11 listed)

Use of any systemic anticancer or immunomodulator treatment, corticosteroid, experimental vaccines, interleukins, interferons, growth factors or intravenous immunoglobulin (IVIG) within 45 days prior to entry into the study.
Pregnancy or lactation.
Allergy and/or sensitivity or any known hypersensitivity to residues present in the vaccine (egg, chicken protein, egg albumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) and/or thimerosal.
Use of alcohol or addiction or other conditions which in the opinion of the site's investigator, may interfere with compliance to the study requirements.
D5. Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry into the study

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
Adjuvanted vaccine against H1N1 influenza virus (GSK)Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.	Biological	3.75 µg of the vaccine on days 0 and 21
Adjuvanted vaccine against H1N1 influenza virus (GSK)Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.	Biological	7.5 µg of the vaccine on days 0 and 21
Adjuvanted vaccine against H1N1 influenza virus (GSK)Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.	Biological	3.75 µg of the vaccine on day 0

Primary outcome

proportions of seroconversion
Time frame: 21 days after vaccination regimen
proportions of seroconversion for influenza A H1N1 in each of the four subsets of HIV-positive patients, and in the control group
proportions of seroprotection
Time frame: 21 days after vaccination regimen
proportions of seroprotection for influenza A H1N1 in each of the four subsets of HIV-positive patients and in the control group
Safety of the A H1N1 vaccine at two different regimens in HIV-infected adults
Time frame: 1 months after vaccination
Safety and tolerability of the vaccine against H1N1 virus in different doses and administration regimens in IV-infected adults

4 secondary outcomes

Prevalence of A H1N1 influenza symptomatic disease in the study population
Time frame: 12 months after vaccination
Persistence of antibodies against H1N1 virus
Time frame: 12 months after vaccination
Changes in HIV viral load and CD4
Time frame: 12 months after vaccination
Cellular immune responses to H1N1 vaccination in HIV-infected patients
Time frame: 12 months after vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Derived from this study: PubMed 22761759Santini-Oliveira M, Camacho LA, Souza TM, Luz PM, Vasconcellos MT, Giacoia-Gripp CB, Morgado MG, Nunes EP, Lemos AS, Ferreira AC, Moreira RI, Veloso VG, Siqueira MM, Grinsztejn B. H1N1pdm09 adjuvanted vaccination in HIV-infected adults: a randomized trial of two single versus two double doses. PLoS One. 2012;7(6):e39310. doi: 10.1371/journal.pone.0039310. Epub 2012 Jun 25.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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 Phase 2 study testing Adjuvanted vaccine against H1N1 influenza virus (GSK) in people with HIV Infection, run by Oswaldo Cruz Foundation at 1 site in Brazil.

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 11 inclusion and 11 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 18 Jul 2018. 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 Brazil. 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

proportions of seroconversion (time frame: 21 days after vaccination regimen). The study lists 3 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 NCT01155037, 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 18 Jul 2018.