A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Lederle-Praxis Biologicals
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000829

Purpose

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.

Condition	Intervention	Phase
HIV Infections Pneumococcal Infections	Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Biological: Pneumococcal Conjugate Vaccine, Heptavalent Biological: Placebo	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 1999
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine	Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Administered as an injection at 24 months of age Biological: Pneumococcal Conjugate Vaccine, Heptavalent Administered as an injection at 0, 2, 4, and 15 months of age
2: Placebo Comparator Patients receiving placebo vaccine	Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Administered as an injection at 24 months of age Biological: Placebo Administered at 0, 2, 4, and 15 months of age

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.

Eligibility

Ages Eligible for Study:	2 Months to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Antipyretics for rectal temperature >= 100.4 F.
Antiretroviral therapy.

Patients must have:

HIV positivity.
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.

Exclusion Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000829

Hide Study Locations

Locations

United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
San Francisco Gen Hosp
San Francisco, California, United States, 94110
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
United States, New York
Harlem Hosp Ctr
New York, New York, United States, 10037
Cornell Univ Med College
New York, New York, United States, 10021
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Lederle-Praxis Biologicals

Investigators

Study Chair:	James King, Jr, M.D.	University of Maryland School of Medicine
Study Chair:	Sharon Nachman, M.D.	SUNY at Stony Brook

More Information

No publications provided

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG 292
Study First Received:	November 2, 1999
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00000829 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vaccines, Synthetic
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Pneumococcal Infections
Bacterial Vaccines

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pneumococcal Infections

Immunologic Deficiency Syndromes
Virus Diseases
Gram-Positive Bacterial Infections
Streptococcal Infections
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009