None listed
Conditions
Interventions
• Group 1 (6 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, from 18 to 60 years of age, will receive a 6-mcg dose of the vaccine on Day 1 and on Day 29 of the study.
Subject Follow up Time: 180 days (booster dose)
Group name:Arm 6 Type of group
•Group 6 (control group with the pneumococcal vaccine). This group of people, 61 years of age and older, will receive an injection with the pneumococcal control vaccine on Day 1 and Day 29 of the study.
Sponsors
CureVac AG,
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be enrolled in this trial only if they meet all of the following criteria: 1. Healthy male and female subjects ≥18 years of age. A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator. 2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. 3. Physical examination without clinically significant findings according to the Investigator’s assessment. 4. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2. 5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). Additional information, please see the study protocol
Exclusion criteria
Exclusion criteria: Subjects will not be enrolled in this trial if they meet any of the exclusion criteria. 1. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 2. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. 3. Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine. 4. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids. 5. Use of hormonal therapy for gender reassignment. 6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection. Additional information, please see the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Collection of solicited local AEs (injection site pain, redness, swelling, and itching) and systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using diary cards (electronic or paper). In addition, other indicators of safety will be collected (e.g., body temperature). Measure:Primary • The frequencies, intensities, and duration of solicited local AEs on each vaccination day and the following 7 days by dose and group. • The frequencies, intensities, duration, and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days by dose and group. • The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days by dose and group. • The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial. On Day 29 and Day 43: • The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies, as measured by enzyme-linked immunosorbent assay (ELISA). • Individual SARS-CoV-2 spike protein-specific antibody levels in serum, as measured by ELISA. • Geometric mean titers (GMTs) of serum SARS-CoV-2 spike protein antibodies, as measured by ELISA. • The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.Individual SARS-CoV-2 neutralizing antibody levels in serum. • GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay Timepoints:day 29 and day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety and reactogenicity data reported during an observation period of at least 24 hours after vaccination will be collected and reviewed by the iSRC. In this review, the iSRC will review all available safety data, but focus specifically on Grade 3 adverse reactions. Based on this review, the iSRC will decide on continuation of enrollment of subjects at this dose level. In case additional dose levels are investigated in this trial, such a dose level will be initiated in additional sentinel subjects in the same manner. Reactogenicity will be assessed daily on each vaccination day and the following 7 days via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using diary cards (electronic or paper). In addition, other indicators of safety will be collected (e.g., body temperature).Diaries will also be used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, subjects will receive a prompt (by e.g., a phone call, software application, or text message) to verify whether they had any health concerns since the last visit. Measure:Secondary On Day 180, Day 208, and Day 393 (Months 6, 7, and 13): • The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies, as measured by ELISA. • Individual SARS-CoV-2 spike protein-specific antibody levels in serum, as measured by ELISA. • GMTs of serum SARS-CoV-2 spike protein antibodies, as measured by ELISA. • The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay. • Individual SARS-CoV-2 neutralizing antibody levels in serum. • GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay. Timepoints:Day 180, day 208, and day 393 (Months 6, 7, and 13) | — |
Countries
Brazil, Panama, Peru
Contacts
Public ContactElizabeth Rospigliosi
RPS PERU S.A.C
Outcome results
None listed