SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
Phase: PHASE4
Conditions: Covid19
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Protocol
Letter of Amendment
SARS-CoV-2 Vaccination 
Strategies in Previously 
Hospitalized and Recovered 
COVID-19 Patients
 3 August 2021
    NCT04969250

ight 
International Network for Strategic Initiatives in Global HIV Trials 
Leadership Group 
University of Minnesota 
2221 University Avenue Southeast, Suite 200 
Minneapolis MN USA 55414-3080 
Letter of Amendment #1 
Date: 
03 August 2021 
To: 
Site Investigators and Study Staff 
Institutional Review Boards/Ethics Committees 
From: 
INSIGHT 016 Study Team (Jens Lundgren, Protocol Chair) 
Protocol: INSIGHT 016 Protocol (VATICO) 
Version 1.0, 07 June 2021 
Vaccination for Recovered Inpatients with COVID-19 (VATICO) 
Subject: 
Letter of Amendment to (1) Clarify Visit Schedule and (2) Correct Informed Consent 
The following information impacts the INSIGHT 016 (VATICO) study and must be forwarded to 
all responsible Institutional Review Boards (IRBs) and Ethics Committees (ECs) as soon as 
possible for their information and review. This Letter of Amendment (LOA) must be approved by 
all responsible IRBs/ECs, as well as any other entities as applicable to each site, and per the 
policies and procedures of each site. 
Information to be Clarified: 
(1) Protocol:
In Section 9.1 (Screening/Baseline and Follow-up Assessments), the description of Figure 2
includes the text, "Every 4 vveeks from baseline through Week 24, all participants will be
contacted either for a face-to-face visit (indicated in figure) or by phone." It then refers the
reader to Appendix B (Schedule of Assessments), but the contacts are not listed. These 4-
weekly contacts are referenced in the sample informed consent (Appendix A), and are the
intent of the protocol.
As shown in Figure 2, in-person visits are required for all participants at Weeks 12, 24, and
48. Additional in-person visits are required for vaccination at Week 4 or Week 16, for those
randomized to receive two doses of vaccine. Otherwise, 4-weekly contacts will be by phone
or other electronic means at Weeks 4 (all except group 12, being seen in person for
vaccination), 8, 16 (all except group D2, being seen in person for vaccination), and 20.
There is no structured data collection or study procedures to be conducted at these contacts;
they are intended to maintain contact with the participant and guide them through the
protocol.
(2) Informed Consent Form:
Under WHAT DO I HAVE TO DO IF I AM IN THIS STUDY?" (page 41 in the main protocol
document) the last sentence of the first paragraph states, "If you have already been
phone: 612-626-8887 • fax: 612-624-2819 • www.insight-trials.org 

vaccinated, you cannot be in this study.”  This is incorrect.  Per exclusion criterion 1 (Section 
7.2), individuals who were vaccinated before randomization into TICO are eligible to 
participate in VATICO. 
 
Amendment 
(1) Protocol: 
In Section 9.1.2 (Follow-up Assessments) the following is added as paragraph 4: 
Participants will be contacted every 4 weeks through Week 24.  At 4-weekly timepoints 
where there is not already participant contact for vaccination or data collection, this 
will occur by phone or other electronic medium.  These contacts are intended to keep 
participants engaged and assist them in following their randomized vaccination 
schedule. 
 
Footnote 7 is added to the table in Appendix B (Overview of Study Procedures): 
7.  All participants will have study contact every 4 weeks.  This will occur by phone or 
other electronic medium if there are no other study requirements at that timepoint. 
 
(2) Informed Consent Form: 
The Sample Informed Consent (Appendix A) has been amended as follows 
Under WHAT DO I HAVE TO DO IF I AM IN THIS STUDY?” (page 41 in the main protocol 
document) the last sentence of the first paragraph now reads, “If you got vaccinated after 
you joined the TICO study, you cannot be in this study.”  Version 1.1 of the Sample 
Informed Consent, dated 03 August 2021, accompanies this LOA. 
 
Implementation: 
• 
This amendment will be incorporated into the next formal protocol revision (version 2.0). 
• 
This LOA and revised consent should be submitted to the IRBs/ECs per institutional policy 
and approved prior to implementation. 
• 
A copy of this LOA should be filed in the site study binders along with the current protocol.