Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years (NVX_PCV20)

Medical University of Vienna

Status and phase: Not yet enrolling; Phase 4

Conditions: COVID-19; Pneumococcal Infections

Treatments: Biological: NVX; Biological: Placebo; Biological: PCV20

Study type: Interventional

Funder types: Other

Identifiers

NCT05767606

NVX_PCV20_V2.1

Details and patient eligibility

About

Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone.

The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms.

The outcome will be the antibody levels after 28 days.

Enrollment: 256 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 60 years or older
• Males and females
• Able and willing (in the investigator's opinion) to comply with all study requirements.
• Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago
• Only applicable for women: last menstrual bleeding more than one year ago

Exclusion criteria

• Use of immunosuppressants
• Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
• Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
• History of Covid-19 within 16 weeks before study vaccination
• Previous pneumococcal vaccination
• Contraindication against any ingredient of the NVX or the PCV20 vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 4 patient groups, including a placebo group

NVX arm

Active Comparator group

Description:

NVX plus placebo

Treatment:

Biological: NVX

PCV20 arm

Active Comparator group

Description:

PCV20 (Apexxnar®) plus placebo

Treatment:

Biological: PCV20

Combination arm

Experimental group

Description:

NVX plus PCV20

Treatment:

Biological: NVX

Biological: PCV20

Placebo arm

Placebo Comparator group

Description:

Placebo (normal saline) plus placebo

Treatment:

Biological: Placebo