HivPhase 4MENPINCT04875819

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

A Phase 4 study testing Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine and 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine in people with Hiv and Meningococcal Infections, run by Thomas Benfield at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hiv, Meningococcal Infections, Pneumococcal Infections
What is being tested?: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine and 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteDenmark
Study dates: 28 Apr 2021to Dec 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Seropositive for HIV-1
Recipient of ART
Plasma HIV-RNA < 500 copies/ml
Patients written consent obtained

Who cannot join

Pregnancy or breastfeeding
History of meningococcal or pneumococcal vaccination
Allergies towards any of the vaccine components
Temperature > 38 ᵒC
Sign of bacterial infection
Previous known or suspected disease caused by N. meningitidis

Show all 12Show fewer

Active AIDS associated illness
Active malignancy
End-stage renal or liver disease
Bleeding disorder
Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month
Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michaela Tinggaard, M.D. contact

22326800

michaela.tinggaard@regionh.dk

Denmark1 site, 1 recruiting

Hvidovre Hospital
Hvidovre, 2650
Michaela Tinggaard, +4522326800, michaela.tinggaard@regionh.dk
Recruiting

Other trials in Denmark

About this study

Official title: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

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.

Conditions: Hiv, Meningococcal Infections, Pneumococcal Infections
Being tested: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Medical subject headings: Acquired Immunodeficiency Syndrome, Meningococcal Infections, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccineDrug
Also called Menveo® and Bexsero®
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 vaccineDrug
Also called Prevenar13® and Pneumovax23®
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.

Study groups in NCT04875819
Study group	Role	What they receive
Menveo + Bexsero	Experimental	Not described Receives: Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
Prevenar13 + Pneumovax23	Experimental	Not described Receives: Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
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.
Measured: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
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)
Measured: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination

Secondary outcomes (5)

Number of participants with immediate adverse events
Measured: 30 minutes post-vaccination
Number of participants with short term adverse events
Measured: Day 5 post vaccination
Number of participants with long term adverse events
Measured: Day 90 post-vaccination
Streptococcus pneumoniae carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Measured: Baseline and day 30 post-vaccination
Neisseria meningitidis carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Measured: Baseline and day 30 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 2021Dec 2026

First posted6 May 2021
Study start28 Apr 2021
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 55 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04875819
Sponsor's protocol ID: H-19001166
Other IDs: 2020-000863-22
Acronym: MENPI
Status last verified: May 2021
First submitted: 12 Apr 2021
Last updated: 6 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731.
PubMed 24166695
Simmons RD, Kirwan P, Beebeejaun K, Riordan A, Borrow R, Ramsay ME, Delpech V, Lattimore S, Ladhani S. Risk of invasive meningococcal disease in children and adults with HIV in England: a population-based cohort study. BMC Med. 2015 Dec 9;13:297. doi: 10.1186/s12916-015-0538-6.
PubMed 26654248
Harboe ZB, Larsen MV, Ladelund S, Kronborg G, Konradsen HB, Gerstoft J, Larsen CS, Pedersen C, Pedersen G, Obel N, Benfield T. Incidence and risk factors for invasive pneumococcal disease in HIV-infected and non-HIV-infected individuals before and after the introduction of combination antiretroviral therapy: persistent high risk among HIV-infected injecting drug users. Clin Infect Dis. 2014 Oct 15;59(8):1168-76. doi: 10.1093/cid/ciu558. Epub 2014 Jul 17.
PubMed 25038114
MacNeil JR, Rubin LG, Patton M, Ortega-Sanchez IR, Martin SW. Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons - Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2016 Nov 4;65(43):1189-1194. doi: 10.15585/mmwr.mm6543a3.
PubMed 27811836
Lujan-Zilbermann J, Warshaw MG, Williams PL, Spector SA, Decker MD, Abzug MJ, Heckman B, Manzella A, Kabat B, Jean-Philippe P, Nachman S, Siberry GK; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team. Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus. J Pediatr. 2012 Oct;161(4):676-81.e2. doi: 10.1016/j.jpeds.2012.04.005. Epub 2012 May 22.
PubMed 22622049
Frota ACC, Ferreira B, Harrison LH, Pereira GS, Pereira-Manfro W, Machado ES, de Oliveira RH, Abreu TF, Milagres LG, Hofer CB. Safety and immune response after two-dose meningococcal C conjugate immunization in HIV-infected children and adolescents in Rio de Janeiro, Brazil. Vaccine. 2017 Dec 15;35(50):7042-7048. doi: 10.1016/j.vaccine.2017.10.043. Epub 2017 Oct 31.
PubMed 29100708
Pedersen RH, Lohse N, Ostergaard L, Sogaard OS. The effectiveness of pneumococcal polysaccharide vaccination in HIV-infected adults: a systematic review. HIV Med. 2011 Jul;12(6):323-33. doi: 10.1111/j.1468-1293.2010.00892.x. Epub 2010 Nov 8.
PubMed 21059168
Lee KY, Tsai MS, Kuo KC, Tsai JC, Sun HY, Cheng AC, Chang SY, Lee CH, Hung CC. Pneumococcal vaccination among HIV-infected adult patients in the era of combination antiretroviral therapy. Hum Vaccin Immunother. 2014;10(12):3700-10. doi: 10.4161/hv.32247.
PubMed 25483681
Sogaard OS, Schonheyder HC, Bukh AR, Harboe ZB, Rasmussen TA, Ostergaard L, Lohse N. Pneumococcal conjugate vaccination in persons with HIV: the effect of highly active antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1315-22. doi: 10.1097/QAD.0b013e328339fe0b.
PubMed 20559037
Rodriguez-Barradas MC, Serpa JA, Munjal I, Mendoza D, Rueda AM, Mushtaq M, Pirofski LA. Quantitative and Qualitative Antibody Responses to Immunization With the Pneumococcal Polysaccharide Vaccine in HIV-Infected Patients After Initiation of Antiretroviral Treatment: Results From a Randomized Clinical Trial. J Infect Dis. 2015 Jun 1;211(11):1703-11. doi: 10.1093/infdis/jiu819. Epub 2014 Dec 23.
PubMed 25538270

Interested in taking part?

Michaela Tinggaard, M.D.

22326800

michaela.tinggaard@regionh.dk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04875819
Acronym / sponsor ID: MENPI / H-19001166
Conditions: Hiv, Meningococcal Infections, Pneumococcal Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 55 participants (estimated)
Lead sponsor: Thomas BenfieldUniversity, hospital or other
Study start: 28 Apr 2021 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 6 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Menveo + Bexsero	Experimental	Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
Prevenar13 + Pneumovax23	Experimental	Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years
Seropositive for HIV-1
Recipient of ART
Plasma HIV-RNA < 500 copies/ml
Patients written consent obtained

Key exclusion criteria (12 listed)

Pregnancy or breastfeeding
History of meningococcal or pneumococcal vaccination
Allergies towards any of the vaccine components
Temperature > 38 ᵒC
Sign of bacterial infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccineAlso: Menveo® and Bexsero®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.	Drug	Menveo + Bexsero
13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccineAlso: Prevenar13® and Pneumovax23®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.	Drug	Prevenar13 + Pneumovax23

Primary outcome

Change in immunogenic response from baseline, Menveo
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
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.
Change in immunogenic response from baseline, Bexsero
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
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.
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
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)

5 secondary outcomes

Number of participants with immediate adverse events
Time frame: 30 minutes post-vaccination
Number of participants with short term adverse events
Time frame: Day 5 post vaccination
Number of participants with long term adverse events
Time frame: Day 90 post-vaccination
Streptococcus pneumoniae carriage rates
Time frame: Baseline and day 30 post-vaccination
Neisseria meningitidis carriage rates
Time frame: Baseline and day 30 post-vaccination

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
Background: PubMed 24166695Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731.
Background: PubMed 26654248Simmons RD, Kirwan P, Beebeejaun K, Riordan A, Borrow R, Ramsay ME, Delpech V, Lattimore S, Ladhani S. Risk of invasive meningococcal disease in children and adults with HIV in England: a population-based cohort study. BMC Med. 2015 Dec 9;13:297. doi: 10.1186/s12916-015-0538-6.
Background: PubMed 25038114Harboe ZB, Larsen MV, Ladelund S, Kronborg G, Konradsen HB, Gerstoft J, Larsen CS, Pedersen C, Pedersen G, Obel N, Benfield T. Incidence and risk factors for invasive pneumococcal disease in HIV-infected and non-HIV-infected individuals before and after the introduction of combination antiretroviral therapy: persistent high risk among HIV-infected injecting drug users. Clin Infect Dis. 2014 Oct 15;59(8):1168-76. doi: 10.1093/cid/ciu558. Epub 2014 Jul 17.
Background: PubMed 27811836MacNeil JR, Rubin LG, Patton M, Ortega-Sanchez IR, Martin SW. Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons - Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2016 Nov 4;65(43):1189-1194. doi: 10.15585/mmwr.mm6543a3.
Background: PubMed 22622049Lujan-Zilbermann J, Warshaw MG, Williams PL, Spector SA, Decker MD, Abzug MJ, Heckman B, Manzella A, Kabat B, Jean-Philippe P, Nachman S, Siberry GK; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team. Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus. J Pediatr. 2012 Oct;161(4):676-81.e2. doi: 10.1016/j.jpeds.2012.04.005. Epub 2012 May 22.
Background: PubMed 29100708Frota ACC, Ferreira B, Harrison LH, Pereira GS, Pereira-Manfro W, Machado ES, de Oliveira RH, Abreu TF, Milagres LG, Hofer CB. Safety and immune response after two-dose meningococcal C conjugate immunization in HIV-infected children and adolescents in Rio de Janeiro, Brazil. Vaccine. 2017 Dec 15;35(50):7042-7048. doi: 10.1016/j.vaccine.2017.10.043. Epub 2017 Oct 31.
Background: PubMed 21059168Pedersen RH, Lohse N, Ostergaard L, Sogaard OS. The effectiveness of pneumococcal polysaccharide vaccination in HIV-infected adults: a systematic review. HIV Med. 2011 Jul;12(6):323-33. doi: 10.1111/j.1468-1293.2010.00892.x. Epub 2010 Nov 8.
Background: PubMed 25483681Lee KY, Tsai MS, Kuo KC, Tsai JC, Sun HY, Cheng AC, Chang SY, Lee CH, Hung CC. Pneumococcal vaccination among HIV-infected adult patients in the era of combination antiretroviral therapy. Hum Vaccin Immunother. 2014;10(12):3700-10. doi: 10.4161/hv.32247.
Background: PubMed 20559037Sogaard OS, Schonheyder HC, Bukh AR, Harboe ZB, Rasmussen TA, Ostergaard L, Lohse N. Pneumococcal conjugate vaccination in persons with HIV: the effect of highly active antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1315-22. doi: 10.1097/QAD.0b013e328339fe0b.
Background: PubMed 25538270Rodriguez-Barradas MC, Serpa JA, Munjal I, Mendoza D, Rueda AM, Mushtaq M, Pirofski LA. Quantitative and Qualitative Antibody Responses to Immunization With the Pneumococcal Polysaccharide Vaccine in HIV-Infected Patients After Initiation of Antiretroviral Treatment: Results From a Randomized Clinical Trial. J Infect Dis. 2015 Jun 1;211(11):1703-11. doi: 10.1093/infdis/jiu819. Epub 2014 Dec 23.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Michaela Tinggaard, M.D. contact

22326800

michaela.tinggaard@regionh.dk

Michaela Tinggaard, M.D. principal investigator

Department of Infectious Diseases, Hvidovre Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michaela Tinggaard, M.D. (22326800, michaela.tinggaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in immunogenic response from baseline, Menveo (time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875819, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.