COVID-19 vaccination of vulnerable populations (COVULPOP)

Not Applicable

• Conditions: COVID-19 vaccine response; COVID-19; Inflammatory and Immune System - Normal development and function of the immune system; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12621001492842
• Lead Sponsor: Prof Katie Flanagan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Younger adults: aged 18 to 45 years, healthy with no major co-morbidities .
Elderly: 65 years of age or older with or without co-morbidities.
Pregnant women: healthy uncomplicated pregnancy at any stage of gestation
All participants:
- Ability to communicate in English
- Ability to communicate by mobile telephone and text messaging
- Written informed consent to participate in the trial

Exclusion Criteria

- Outside the specified age range
- Inability to speak and/or understand English
- Diagnosed with a cognitive impairment or inability to provide informed consent
- Known allergy or contraindication to COVID-19 (or dTap or influenza vaccination in pregnant women)
- Unwilling to give consent to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement and comparison of the vaccine-induced cellular immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.];Measurement and comparison of the vaccine-induced humoral immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.]

Secondary Outcome Measures

Name	Time	Method
Assessment of mood as a comorbidity for clinical interventions, as well as the impact of attitudes to vaccination on mood, using the depression, anxiety and stress survey (DASS-21).[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).];Assessment of antenatal depression in pregnant women, using the Edinburgh postnatal depression scale (EPDS).[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).];Assessment of both nutrition and lifestyle using the CardioMed survey tool.[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).]