Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

NCT01135082 | Completed

• 1 other identifier: HIV-NAT 135
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Keywords

immunogenicity; safety; Pneumococcal conjugate vaccine; HIV infected children; 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

Outcome Measures

Primary Outcomes (1)

• immunogenicity

  Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.

  28 days

Secondary Outcomes (2)

• Safety

  28 days

• compare serotype

  28 days

Study Arms (2)

1

OTHER

Receive valent pneumococcal conjugated vaccine in HIV - infected children

Biological: valent pneumococcal conjugated vaccine

2

OTHER

Receive valent pneumococcal conjugated vaccine in HIV negative children

Biological: valent pneumococcal conjugated vaccine

Interventions

valent pneumococcal conjugated vaccine BIOLOGICAL

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.

1; 2

Eligibility Criteria

• Age: 2 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• HIV - infected children
• HIV infected individuals
• Age between 2 months to 9 years
• Signed written informed consent
• HIV - exposed negative children
• Maternal HIV infection, documented prior to delivery.
• Age between 2 months to 9 years
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University: collaborator

Study Sites (2)

HIV-NAT, The Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

Pediatric infectious diseases section, King Chulalongkorn Memorial hospital

Bangkok, 10330, Thailand

Location

Related 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. Vaccine. 2011 Aug 11;29(35):5886-91. doi: 10.1016/j.vaccine.2011.06.072. Epub 2011 Jul 3.

  PMID: 21729732 RESULT

Related Links

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

Study Officials

• Chitsanu Pancharoen, MD

  Pediatric infectious diseases unit, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

TH (2)