HIV InfectionsPhase 1NCT00000829
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
A Phase 1 study testing Pneumococcal Vaccine, Polyvalent (23-valent) and Pneumococcal Conjugate Vaccine, Heptavalent in people with HIV Infections and Pneumococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 33 sites in 2 countries.
Trial summary
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- HIV Infections, Pneumococcal Infections
- What is being tested?
- Pneumococcal Vaccine, Polyvalent (23-valent) and Pneumococcal Conjugate Vaccine, Heptavalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Start not givento Oct 1999
- Phase
- Phase 1
- 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 2 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antipyretics for rectal temperature >= 100.4 F.
- Antiretroviral therapy.
- Patients must have:
- HIV positivity.
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- Birth weight at least 1800 g (3.75 lb).
- Consent and compliance of parent or guardian.
- NOTE:
- Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Enrollment in HIV vaccine trials.
- Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
- Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
- Hypogammaglobulinemia.
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- Concurrent Medication:
- Excluded:
- Prophylactic antipyretics.
- Patients with the following prior conditions are excluded:
- Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.
- Prior Medication:
- Excluded:
- Any prior pneumococcal vaccine.
- Measles vaccine within 1 month prior to study vaccination.
- Any other routine vaccine within 1 week prior to study vaccination.
- Any immunosuppressant agent, including prednisone, for more than 6 weeks.
- Prior Treatment:
- Excluded:
- Blood products within 56 days prior to study vaccination.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States31 sites
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, 30306
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 021155724
Cook County Hosp.
Chicago, Illinois, 60612
Chicago Children's CRS
Chicago, Illinois, 606143394
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 606371470
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
DUMC Ped. CRS
Durham, North Carolina, 277103499
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Usc La Nichd Crs
Los Angeles, California, 90033
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 089030019
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 701122699
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016
Columbia IMPAACT CRS
New York, New York, 10032
Incarnation Children's Ctr.
New York, New York, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
NJ Med. School CRS
Newark, New Jersey, 071072198
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 946091809
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 920930672
San Francisco Gen. Hosp.
San Francisco, California, 94110
UCSF Pediatric AIDS CRS
San Francisco, California, 941430105
UW School of Medicine - CHRMC
Seattle, Washington, 981050371
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 117948111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
Puerto Rico2 sites
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 009365067
San Juan City Hosp. PR NICHD CRS
San Juan
About this study
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination.
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Read the detailed description
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
- Conditions
- HIV Infections, Pneumococcal Infections
- Being tested
- Pneumococcal Vaccine, Polyvalent (23-valent), Pneumococcal Conjugate Vaccine, Heptavalent, Placebo
- Keywords
- Vaccines, Synthetic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pneumococcal Infections, Bacterial Vaccines
- Medical subject headings
- HIV Infections, Pneumococcal Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Vaccine, Polyvalent (23-valent)Biological
Administered as an injection at 24 months of age
Pneumococcal Conjugate Vaccine, HeptavalentBiological
Administered as an injection at 0, 2, 4, and 15 months of age
PlaceboBiological
Administered at 0, 2, 4, and 15 months of age
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine Receives: Biological: Pneumococcal Vaccine, Polyvalent (23-valent); Biological: Pneumococcal Conjugate Vaccine, Heptavalent |
| 2 | Placebo comparator | Patients receiving placebo vaccine Receives: Biological: Pneumococcal Vaccine, Polyvalent (23-valent); Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Measured: Throughout study
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
Measured: Throughout study
Secondary outcomes (4)
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Measured: Prior to 4th vaccination and at 1 month after 4th vaccination
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
Measured: Throughout study
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
Measured: At a time after the 3rd vaccination and at a time after the 4th vaccination
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Lederle-Praxis Biologicals
- Responsible party
- Sponsor
- Investigators
- James King, Jr, M.D., Study chair, University of Maryland, College ParkSharon Nachman, M.D., Study chair, SUNY at Stony Brook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000829
- Sponsor's protocol ID
- ACTG 292
- Other IDs
- 11268
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
- ClinicalTrials.gov ID
- NCT00000829
- Acronym / sponsor ID
- ACTG 292
- Conditions
- HIV Infections, Pneumococcal Infections
- Keywords
- Vaccines, Synthetic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pneumococcal Infections, Bacterial Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Lederle-Praxis Biologicals
- Study completion
- Oct 1999 (actual)
- First posted
- 31 Aug 2001 (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.
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination.
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Detailed description
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Pneumococcal Vaccine, Polyvalent (23-valent), Biological: Pneumococcal Conjugate Vaccine, HeptavalentPatients receiving intramuscular heptavalent pneumococcal conjugate vaccine |
| 2 | Placebo comparator | Biological: Pneumococcal Vaccine, Polyvalent (23-valent), Biological: PlaceboPatients receiving placebo vaccine |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Antipyretics for rectal temperature >= 100.4 F.
- Antiretroviral therapy.
- HIV positivity.
- Birth weight at least 1800 g (3.75 lb).
- Consent and compliance of parent or guardian.
Key exclusion criteria (20 listed)
- Enrollment in HIV vaccine trials.
- Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
- Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
- Hypogammaglobulinemia.
- Prophylactic antipyretics.
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 |
|---|---|---|
| Pneumococcal Vaccine, Polyvalent (23-valent)Administered as an injection at 24 months of age | Biological | 1, 2 |
| Pneumococcal Conjugate Vaccine, HeptavalentAdministered as an injection at 0, 2, 4, and 15 months of age | Biological | 1 |
| PlaceboAdministered at 0, 2, 4, and 15 months of age | Biological | 2 |
Primary outcome
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Time frame: Throughout study
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
Time frame: Throughout study
4 secondary outcomes
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Time frame: Prior to 4th vaccination and at 1 month after 4th vaccination
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
Time frame: Throughout study
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
Time frame: At a time after the 3rd vaccination and at a time after the 4th vaccination
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters
Time frame: Throughout study
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 28 Oct 2021.
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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.
James King, Jr, M.D. study chair
University of Maryland, College Park
Sharon Nachman, M.D. study chair
SUNY at Stony Brook
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumococcal Vaccine, Polyvalent (23-valent) and Pneumococcal Conjugate Vaccine, Heptavalent in people with HIV Infections and Pneumococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 33 sites in 2 countries.
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 20 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Puerto Rico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection (time frame: Throughout study). 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?
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 28 Oct 2021.