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Trial registered on ANZCTR

Registration number

ACTRN12621001492842

Ethics application status

Approved

Date submitted

26/10/2021

Date registered

2/11/2021

Date last updated

5/10/2022

Date data sharing statement initially provided

2/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

COVID-19 vaccination of vulnerable populations (COVULPOP)

Scientific title

Profiling the immune response to COVID-19 vaccination in vulnerable populations (COVULPOP).

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

COVULPOP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19 vaccine response

COVID-19

Condition category

Condition code

Inflammatory and Immune System

Normal development and function of the immune system

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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.

Timepoint [1]

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.

Primary outcome [2]

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.

Timepoint [2]

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 [1]

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).

Timepoint [1]

24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).

Secondary outcome [2]

Assessment of antenatal depression in pregnant women, using the Edinburgh postnatal depression scale (EPDS).

Timepoint [2]

24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).

Secondary outcome [3]

Assessment of both nutrition and lifestyle using the CardioMed survey tool.

Timepoint [3]

24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

21/11/2022

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Katie Flanagan

Address

Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Tasmania Research Integrity and Ethics Unit

Ethics committee address [1]

University of Tasmania, Newnham Drive, Newnham, Launceston TAS 7250

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/09/2021

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Katie Flanagan

Address

Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250

Country

Australia

Phone

+61 3 6777 4081

Fax

[email protected]

Contact person for public queries

Name

Katie Flanagan

Address

Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250

Country

Australia

Phone

+61 3 6777 4081

Fax

[email protected]

Contact person for scientific queries

Name

Katie Flanagan

Address

Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250

Country

Australia

Phone

+61 3 6777 4081

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13784	Informed consent form					383027-(Uploaded-26-10-2021-11-33-40)-Study-related document.pdf
13785	Ethical approval					383027-(Uploaded-26-10-2021-11-33-52)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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