None listed
Conditions
Brief summary
The current provisional or emergency use approvals of COVID-19 vaccines are based on interim phase 3 clinical trial results indicating that these vaccines have an acceptable safety profile, are immunogenic and protect against symptomatic COVID-19. To date, it has not been possible to obtain robust safety and immunogenicity data for pregnant women or the very elderly; two groups at increased risk of developing severe COVID-19, because the initial trials focused on healthy adults. It is probable that the elderly will have less robust responses to COVID-19 vaccination, whereas pregnant women may or may not respond similarly to non-pregnant adults. We propose to conduct COVID-19 vaccination studies in these vulnerable groups and compare vaccine-specific antibody and T cell responses to those induced in young healthy non-pregnant individuals. The COVID-19 pandemic has seen the rapid development of multiple candidate COVID-19 vaccines, many using new platforms never before used for licensed human vaccines, including mRNA and viral vectors vaccines. While we know that they elicit SARS-CoV-2 specific antibody and T cell responses, we have no information about their broad effects on the immune system. Systems vaccinology is a newly emerging approach to studying vaccine effects by utilising various ‘omics’ platforms such as transcriptomics and metabolomics to provide unique insights into mechanisms of adverse events, reactogenicity and immunogenicity of vaccines. We will therefore use an exploratory systems vaccinology approach to interrogate the broad immunological effects of COVID-19 vaccination on the immune system of participants, providing important data for their future deployment and development. The interrogation of responses in those more vulnerable to the serious outcomes of COVID-19, and also more likely to have suboptimal immune responses, may identify mechanisms and strategies to optimise COVID-19 vaccines for vulnerable populations. Given the well-established links between nutrition, microbiome, mood and the immune system, there is a strong rationale and urgent need to conduct multidisciplinary studies that include both molecular and lifestyle factors. Standard questionnaires will therefore be administered prior to each blood collection (pre- and post-vaccination) to assess mood, nutrition and lifestyle. The results will be correlated with the key molecular findings from the immunological analyses.
Interventions
For all participants apart from pregnant women, participation will require that they are due to have a COVID-19 vaccination. Pregnant women who don’t want a COVID-19 vaccination will have the opportunity to participate at the time of their next scheduled pregnancy vaccine – either dTap, QIV or both.
The COVID-19 vaccine can be first dose, second dose or subsequent booster doses. If the participant has had a COVID-19 vaccine (1 or 2 doses) they will be asked to participate for their second or b
For all participants apart from pregnant women, participation will require that they are due to have a COVID-19 vaccination. Pregnant women who don’t want a COVID-19 vaccination will have the opportunity to participate at the time of their next scheduled pregnancy vaccine – either dTap, QIV or both. The COVID-19 vaccine can be first dose, second dose or subsequent booster doses. If the participant has had a COVID-19 vaccine (1 or 2 doses) they will be asked to participate for their second or booster dose only. If they have not had a COVID-19 vaccination, they will be invited to provide venous blood samples for both their primary vaccinations. Vaccines will be administered intramuscularly into the deltoid muscle by a trained nurse. Participants presenting for their first dose will be offered the opportunity to provide 24hr, 1 week and 4-week samples at the time of their second doses too. The study will initially focus on the Pfizer mRNA COVID-19 vaccine Comirnaty in the younger age groups since this is the preferred choice in Australia for people <60 years of age, but will test other vaccines such as the Moderna mRNA vaccine or Novavax’s spike protein vaccine once available and authorised for use in Australia. Younger people may also choose to have the AstraZeneca vaccine. Older individuals may be offered COVID-19 Vaccine AstraZeneca or Comirnaty, depending on availability, but other vaccines may also become available to them. Anyone who has a mixed schedule with 2 different vaccines for any reason (e.g. severe adverse reaction to the first vaccine, original vaccine not available, personal choice) will remain eligible for the study since there are very limited data about the effects of using mixed schedules and this will provide valuable information. The second dose of Pfizer/Moderna or other licensed COVID-19 vaccine will be given at ~4 weeks, thus the 4-week bleed will serve as the baseline for the second vaccination. The second dose of COVID-19 Vaccine AstraZeneca can be given at 4-12 weeks, but most are given at 12 weeks. Therefore, an additional dose 2 baseline sample will need to be collected. Younger participants including pregnant women may request AstraZeneca and participants can also be given a mixed schedule e.g. AZ/Pfizer if clinically indicated or requested.
Sponsors
Prof Katie Flanagan
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Outcome results
None listed