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Pneumococcal conjugate vaccine trial: PNEUVAC TRIAL

Investigation of the humoral immune response to pneumococcal polysaccharides and the role of a conjugate pneumococcal vaccine in secondary prevention of invasive pneumococcal disease in human immunodeficiency virus (HIV)-infected Africans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54494731
Enrollment
320
Registered
2005-07-22
Start date
2003-02-28
Completion date
Unknown
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive pneumococcal disease in HIV-infected Africans Infections and Infestations Invasive pneumococcal disease

Interventions

Participants are recruited from individuals who are convalescing from a known invasive pneumococcal disease event. They are randomised into two arms in a 1:1 ratio to receive two doses of vaccine one

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed case of IPD discharged from hospital 2. Resident of Blantyre and its immediately neighbouring districts 3. Willing to attend Queen Elizabeth Central Hospital (QECH) when sick 4. Aged over 15 years, either sex 5. Willing to have HIV testing performed on stored serum

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previous pneumococcal vaccine 3. Active acute systemic illness - following recovery participant may be recruited 4. Past hypersensitivity reaction to vaccination 5. Bed-ridden or life expectancy judged to be less than three months

Design outcomes

Primary

MeasureTime frame
Vaccine serotype invasive pneumococcal disease

Secondary

MeasureTime frame
1. All invasive pneumococcal disease death 2. All cause pneumonia

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026