Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children

NCT00099658 | Unknown DMC

• 4 other identifiers: CIPRA-SA Project 4U19AI053217CIPRAProject 4
• Study Type: interventional
• Target: 579
• Locations: 0 countries
• Sites: N/A

Brief Summary

Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein conjugate vaccine (PncCV) in HIV infected and uninfected children. The study will also determine the safety of and immune response to Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will occur at two hospitals in South Africa, and all HIV infected infants participating in this study must also be coenrolled in the CIPRA SA-Project 2 study.

Conditions

HIV Infections; Pneumococcal Infections

Keywords

MTCT

Outcome Measures

Primary Outcomes (3)

• Response rate to PncCV among children in Group 2 compared to those in Groups 1 and 3

  At Weeks 3 and 6

• Response rate to PncCV among children in Group 2 compared to those in Groups 1 and 3 before receiving booster vaccine dose

  At Weeks 64 through 76

• Vaccine safety profiles after each of the three primary doses of PncCV and booster doses of PncCV and HibCV

  Throughout study

Study Arms (5)

1

EXPERIMENTAL

HIV-uninfected infants born to HIV-uninfected mothers

Biological: Pneumococcal polysaccharide-protein conjugate vaccine

2

EXPERIMENTAL

HIV-infected infants in CDC Disease Category 1 who were randomly assigned to the delayed therapy arm (Arm 1) of CIPRA SA-Project 2

Biological: Pneumococcal polysaccharide-protein conjugate vaccine

3

EXPERIMENTAL

HIV-infected infants in CDC Disease Category 1 who were randomly assigned to the first early therapy arm (Arm 2) of CIPRA SA-Project 2

Biological: Pneumococcal polysaccharide-protein conjugate vaccine

4

EXPERIMENTAL

HIV-infected infants in CDC Disease Category 2 or 3 who were randomly assigned to the second early therapy arm (Arm 3) of CIPRA SA-Project 2

Biological: Pneumococcal polysaccharide-protein conjugate vaccine

5

EXPERIMENTAL

HIV-uninfected infants born to HIV infected mothers

Biological: Pneumococcal polysaccharide-protein conjugate vaccine

Interventions

Pneumococcal polysaccharide-protein conjugate vaccine BIOLOGICAL

Injection administered three times before the age of 24 weeks

Also known as: PncCV

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 4 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight of at least 2 kg (4.4 lbs)
• Written informed consent from parent or guardian
• Mother's HIV status documented after 24th week of pregnancy, if her infant joins Group 5 and is HIV uninfected
• Parent or guardian of infant intends to remain in the study area for the duration of the trial
• HIV infected
• Participating in CIPRA SA-Project 2

You may not qualify if:

• Blood products prior to study entry
• Immunosuppressant agents for more than 2 weeks, within 1 week of study entry
• Unable to tolerate oral medications
• Presence of any major, life-threatening congenital defect
• Acute illness or fever requiring hospitalization within 72 hours of immunization
• Grade 2 vaccine-related allergic reaction
• Grade 3 or 4 clinical or laboratory toxicity related to vaccination
• Use of any antiretroviral therapies other than those allowed in CIPRA SA-Project 2. Infants who received antiretroviral drugs used to prevent mother-to-infant HIV transmission are eligible for this study.
• Use of investigational drugs, systemic cytotoxic chemotherapy, or interleukin or other immune modulators
• Require certain medications
• Vaccines prior to study entry. Infants who have received bacille Calmette-Guerin or oral polio vaccines are not excluded.

Sponsors & Collaborators

• CIPRA SA: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Related Publications (7)

• Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N; Vaccine Trialists Group. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engl J Med. 2003 Oct 2;349(14):1341-8. doi: 10.1056/NEJMoa035060.

  PMID: 14523142 BACKGROUND

• Madhi SA, Kuwanda L, Cutland C, Holm A, Kayhty H, Klugman KP. Quantitative and qualitative antibody response to pneumococcal conjugate vaccine among African human immunodeficiency virus-infected and uninfected children. Pediatr Infect Dis J. 2005 May;24(5):410-6. doi: 10.1097/01.inf.0000160942.84169.14.

  PMID: 15876939 BACKGROUND

• Madhi SA, Petersen K, Madhi A, Khoosal M, Klugman KP. Increased disease burden and antibiotic resistance of bacteria causing severe community-acquired lower respiratory tract infections in human immunodeficiency virus type 1-infected children. Clin Infect Dis. 2000 Jul;31(1):170-6. doi: 10.1086/313925. Epub 2000 Jul 25.

  PMID: 10913417 BACKGROUND

• Nachman S, Kim S, King J, Abrams EJ, Margolis D, Petru A, Shearer W, Smith E, Moye J, Blanchard S, Hawkins E, Bouquin P, Vink P, Benson M, Estep S, Malinoski F; Pediatric AIDS Clinical Trials Group Study 292 Team. Safety and immunogenicity of a heptavalent pneumococcal conjugate vaccine in infants with human immunodeficiency virus type 1 infection. Pediatrics. 2003 Jul;112(1 Pt 1):66-73. doi: 10.1542/peds.112.1.66.

  PMID: 12837869 BACKGROUND

• Pai VB, Heyneman CA, Erramouspe J. Conjugated heptavalent pneumococcal vaccine. Ann Pharmacother. 2002 Sep;36(9):1403-13. doi: 10.1345/aph.1A048.

  PMID: 12196061 BACKGROUND

• Mutsaerts EAML, Nunes MC, van Rijswijk MN, Klipstein-Grobusch K, Otwombe K, Cotton MF, Violari A, Madhi SA. Measles Immunity at 4.5 Years of Age Following Vaccination at 9 and 15-18 Months of Age Among Human Immunodeficiency Virus (HIV)-infected, HIV-exposed-uninfected, and HIV-unexposed Children. Clin Infect Dis. 2019 Aug 1;69(4):687-696. doi: 10.1093/cid/ciy964.

  PMID: 30418528 DERIVED

• Madhi SA, Izu A, Nunes MC, Violari A, Cotton MF, Jean-Philippe P, Klugman KP, von Gottberg A, van Niekerk N, Adrian PV; CIPRA 4 team. Longitudinal study on Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus nasopharyngeal colonization in HIV-infected and -uninfected infants vaccinated with pneumococcal conjugate vaccine. Vaccine. 2015 May 28;33(23):2662-9. doi: 10.1016/j.vaccine.2015.04.024. Epub 2015 Apr 21.

  PMID: 25910923 DERIVED

Related Links

• Click here for more information about CIPRA-SA Project 2.

MeSH Terms

Conditions

HIV Infections; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Shabir Madhi, MD, MBBCH, Mmed, FCPaeds, PhD

  Chris Hani Baragwanath Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 17, 2004
• First Posted: December 20, 2004
• Study Start: April 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 15, 2011

Record last verified: 2011-02