Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

HIV Clinical Trial

Official title:

The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135082
• Other study ID #: HIV-NAT 135
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: September 3, 2014
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2014
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.

Description:

S. pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged < 5 years had a range of 10.6-28.9 cases per 100,000 persons.[1]

Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged <5 and <3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years [2]

Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children < 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.[3] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.[4] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.[5].

In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 9 Years

Eligibility

Inclusion Criteria:

1. HIV - infected children

• HIV infected individuals

• Age between 2 months to 9 years

• Signed written informed consent

2. HIV - exposed negative children

• Maternal HIV infection, documented prior to delivery.

• Age between 2 months to 9 years

• Signed written informed consent

Exclusion Criteria:

• Active opportunistic infection

• History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid

• Using oral steroid or immunosuppressive drugs

• Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• valent pneumococcal conjugated vaccine
Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.

Locations

Country	Name	City	State
Thailand	HIV-NAT, The Thai Red Cross AIDS Research Center	Bangkok
Thailand	Pediatric infectious diseases section, King Chulalongkorn Memorial hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Thanee C, Pancharoen C, Likitnukul S, Luangwedchakarn V, Umrod P, Phasomsap C, Apornpong T, Chuanchareon T, Butterworth O, Puthanakit T. The immunogenicity and safety of pneumococcal conjugate vaccine in human immunodeficiency virus-infected Thai children — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunogenicity	Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.	28 days	No
Secondary	Safety	Number of adverse events after PCV administration	28 days	Yes
Secondary	compare serotype	Compare proportion of PCV serotype - specific IgG antibody in HIV - infected children by baseline clinical staging, CD4 and viral load.	28 days	No

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)