COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=054-20

Elizabeth Rospigliosi

rospigliosielizabeth@prahs.com

2020-08-20

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Subjects will be enrolled in this trial only if they meet all of the following criteria: 1. Healthy male and female subjects &#8805,18 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) &#8805,18.0 and &#8804,30.0 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

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

4

CureVac AG;

18

100

Brazil;Panama;Peru

Healthy volunteers

N/A

350

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 assayTimepoints:day 29 and day 43

Phase 2

[{"arm_notes": "1 or 2", "treatment_id": 568, "treatment_name": "Hepatitis a vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1 or 2", "treatment_id": 1006, "treatment_name": "Pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "6 mcg;1 or 2;18 to 60 years vs 61 years of age and older", "treatment_id": 364, "treatment_name": "Cvncov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "8 mcg;1 or 2;61 years of age and older", "treatment_id": 364, "treatment_name": "Cvncov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]