Health TrialsbyHealthPanel

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

ConditionsHivMeningococcal InfectionsPneumococcal Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Benfield

About this trial

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.

Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.

Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Seropositive for HIV-1

Recipient of ART

Plasma HIV-RNA < 500 copies/ml

Disqualifiers

Pregnancy or breastfeeding

History of meningococcal or pneumococcal vaccination

Allergies towards any of the vaccine components

Temperature > 38 ᵒC

Trial design

Design model

Crossover

Treatments tested in this trial

  • Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine

    Drug

    One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.

  • 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

    Drug

    One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Menveo + BexseroExperimental treatment 1 intervention
Group B: Prevenar13 + Pneumovax23Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in immunogenic response from baseline, Menveo

A ≥4-fold rise in rabbit complement source (rSBA) for the four serogroups A, C, Y, and W-135. Seroprotection is defined as an rSBA titre ≥1:8 and patients will be classified as previously immune if baseline rSBA is ≥1:8.

Time frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
2

Change in immunogenic response from baseline, Bexsero

A ≥4-fold rise in antibody titers against a panel of four meningococcal serogroup B reference strains between pre-vaccination and post-vaccination timepoints, or a post-vaccination antibody titre ratio of ≥1:4 for individuals who were seronegative before vaccination.

Time frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
3

Change in immunogenic response from baseline, Prevenar13/Pneumovax23

A ≥2-fold rise in serum anti-capsular IgG GMC for 12 shared pneumococcal polysaccharides (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)

Time frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination

Secondary outcomes

1

Number of participants with immediate adverse events

Time frame
30 minutes post-vaccination
2

Number of participants with short term adverse events

Time frame
Day 5 post vaccination
3

Number of participants with long term adverse events

Time frame
Day 90 post-vaccination
4

Streptococcus pneumoniae carriage rates

Proportion of study subject with a culture or PCR positive pharyngeal swab sample

Time frame
Baseline and day 30 post-vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Benfield

Lead sponsor

Hvidovre University Hospital

Sponsor institution

Source ClinicalTrials.gov
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