Pneumococcal Conjugate Vaccine Followup

NCT01414504 | Completed Phase 2

• 1 other identifier: PCVFU927
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants. Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.

Conditions

Immune Tolerance

Keywords

pneumococcal,; pneumococcal polysaccharide vaccine,; challenge dose,; hyporesponsiveness,; Papua New Guinea

Outcome Measures

Primary Outcomes (1)

• Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls.

  Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels.

  2yrs

Secondary Outcomes (2)

• Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation

  2yrs

• Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose

  2yrs

Study Arms (4)

Neonatal PCV + PPV 9 months

ACTIVE COMPARATOR

Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age

Biological: Prevenar + PPV

Infant PCV + PPV at 9 months

ACTIVE COMPARATOR

Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age

Biological: Infant PCV (Prevenar) + PPV at 9 months

No PCV + PPV at 9 months

ACTIVE COMPARATOR

Group 3: Children who only received PPV at 9 months of age

Biological: No Prevenar + PPV at 9 months

Control

ACTIVE COMPARATOR

Group 4: Children who have not received any previous pneumococcal vaccine

Biological: Control

Interventions

Prevenar + PPV BIOLOGICAL

0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs

Neonatal PCV + PPV 9 months

Infant PCV (Prevenar) + PPV at 9 months BIOLOGICAL

0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs

Also known as: Prevenar, Pneumovax23

Infant PCV + PPV at 9 months

No Prevenar + PPV at 9 months BIOLOGICAL

no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs

No PCV + PPV at 9 months

Control BIOLOGICAL

control, 0.1mL Pneumovax at 3-5yrs

Control

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
• Informed parental/guardian consent

You may not qualify if:

• Known HIV infection or other immunosuppressive condition or treatment.
• Prior receipt of 2 doses of pneumococcal polysaccharide vaccine

Sponsors & Collaborators

• William Pomat: lead
• The University of Western Australia: collaborator

Study Sites (1)

PNG Institute of Medical Research

Goroka, Eastern Highlands Province, 441, Papua New Guinea

Location

Related Publications (1)

• van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.

  PMID: 29028802 DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Predictive Value of Tests

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Peter C Richmond, MD

  School of Paediatrics and Child Health, University of Western Australia

  PRINCIPAL INVESTIGATOR

• Deborah Lehmann, MSc

  Telethon Institute for Child Health Research

  PRINCIPAL INVESTIGATOR

• William S Pomat, PhD

  Papua New Guinea Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 11, 2011
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

PA (1)