A meeting of Southern Research’s Institutional Biosafety Committee convened on Thursday,
09 April 2026, in Birmingham, Alabama 35205.
The following participants were present:
Kayton Cherry, Voting Participant
Lamar Jones, Voting Participant
Synthia Mayfield, Voting Participant
La’Wanda Parker, Voting Participant
James Toomey, Voting Participant
Amanda Haley (via Teams), Visitor
Christina Humphries, Ex-Officio
Thorsten Demberg, Visitor
Shahab Fakhari, Visitor (via Teams)
Brooke Warren, Visitor (via Teams)
- Review and Approval of Meeting Agenda
The Acting-Chairperson called the meeting to order. The Acting-Chairperson asked the
committee to review the agenda. A motion was made to approve. A second was made and
by voice vote the agenda was approved. - Review and Approval of Previous Meeting Minutes
- 12 March 2026 – A motion was made to approve. A second was made, and by voice
vote the minutes were approved.
- New Business
- BSO Notes/OSP Reportable Incidents Report – None to report.
- Review and Approval of BPRs and Amendments
R24-04-010SA, Amendment 4
Title: Challenge Study with H5 Influenza Strain in Ferrets
RS: Thorsten Demberg
IBC reviewed, comments and contingencies were received. A motion was made to approve,
a second was made, and by voice vote the BPR amendment was approved.
- Agent Name:
o Orthomyxoviridae / Influenza Virus: Seasonal, HPAI and LPAI (H1, H2, H3, H5, H7,
H9, H10) – full list available in Section 9.0, Appendix of BPR;
o Type 5 adenoviruses: Replication incompetent type 5 adenoviruses;
INSTITUTIONAL BIOSAFETY COMMITTEE
Minutes, Page 2 of 4
o FluMist: Live attenuated quadrivalent influenza vaccine (composed of 4 influenza
viruses: influenza A H1N1, influenza A H3N2, and two lineages of influenza B virus). - Agent Characteristics: Various
- Containment Conditions: A/BSL-2, A/BSL-3
- Sources of the Inserted DNA Sequences:
o In general, reassortant viruses were generated through reverse genetics. In this
case, 6 of the segments of the virus genome come from the mouse adapted (BSL
1/2) PR8 strain. The remaining two segments are the HA and NA segments of the
virus genome and come from the H7, H5, H2 or H9 parental avian influenza. In these
cases, these two segments have been additionally modified to contain attenuating
mutations and have been cleared from select agent and BSL-3 status. These strains
are denoted in the list of viruses in Section 9.0, Appendix, with “…xPR8.”
o The adenovirus vector is non-replicative, E1 deleted, type 5 adenoviruses. The
adenoviral vectors are encoding codon-optimized HA transgenes from the influenza
virus A/California/07/2009 and T cell epitopes from conserved influenza A virus
internal proteins.
o The viruses that compose FluMist contain the backbone of A/Ann Arbor/6/1960 and
the HA and NA segments from currently circulating influenza A H1N1, H3N2 and two
lineages of influenza B virus. - Foreign Gene Expression: Recombinant Adenovirus expressing an Influenza A virus
gene (transgene). - Protein Expressed: DNA/RNA vaccines encoding for influenza virus proteins.
- Applicable Section(s) of the NIH Guidelines: Section III-D-4, Section III-D-7
- Types of Manipulations Planned: Various
Contingency 1: Is section 5.10 correct for this study? It is in regards to SARS-Co V-2 and
this is an influenza study.
Response: The question in 5.10: How do you plan to use the recombinant DNA/RNA? The
response is correct.
The vaccine is against Influenza and it is a mRNA lipid nanoparticle vaccine. The vaccine
will be given IM similar to the approved vaccines for SARS-CoV-2. The mRNA vaccine is
against Influenza; however, the route of administration and the mechanism of action is
expected to be similar to the approved vaccines. The only mRNA vaccines approved in the
United States are currently the vaccines against SARS-CoV-2. The SARS-CoV-2 vaccines
are mentioned for comparison as they are widely known.
R26-04-004NS
Title: Dengue Vaccine Efficacy Pilot Study in NHPs
RS: Thorsten Demberg
IBC reviewed, comments and contingencies were received. A motion was made to approve
with additions, a second was made, and by voice vote the BPR amendment was approved. - Agent Name: Dengue virus type 2 (DENV-2)
- Agent Characteristics: Antigenically distinct, mosquito-borne serotype responsible for
dengue fever - Containment Conditions: A/BSL-2
INSTITUTIONAL BIOSAFETY COMMITTEE
Minutes, Page 3 of 4 - Sources of the Inserted DNA Sequences: Dengue Virus challenge material will be
either shipped by the sponsor and propagated at SR or a Dengue 2 strain that is already
in-house and will be propagated at SR will be used. - Foreign Gene Expression: the mRNA vaccine is designed to express Dengue virus
genes from various serotypes (e.g., envelope gene from Dengue 1, 2, 3 and 4). - Protein Expressed: n/a
- Applicable Section(s) of the NIH Guidelines: Sections III-D, III-D-1, and III-D-4
- Types of Manipulations Planned: Non-human primates will be vaccinated three times
with the vaccine before being challenged with Dengue virus serotype 2. To assess the
levels of induced antibodies, blood will be drawn from the animals during the vaccination
phase and post challenge.
Contingency 1: Section 4.2- Please ensure all users who will work on this project
have up-to-date Dengue training. That training has not been offered since 2024.
Response: Dengue virus can be considered as a blood-born pathogen and as of
08APR2026 133 employees have been trained on the blood-born pathogen policy
(8 in anatomic pathology; 29 in bioanalytic; 2 in clinical pathology; 5 in EHS; 18 in
LAR as well as 2 in sample management).
There is currently no training option specific for Dengue in Veeva.
Dengue specific SOPs can be found in Veeva. The Focus Reduction Neutralization
Test SOP was read by 14 employees and the Histopathology Evaluation for Dengue
and Yellow Fever Neurovirulence Testing as been read and acknowledged by 2
employees. If additional training on Dengue is needed, an in-person session or a
PDF can be emailed to people involved in the study.
Contingency 2: Section 5.11(d) – Please indicate in vivo activities that will utilize a
BSC.
Response: The vaccine material as well as challenge material will be drawn up into
syringes in BSC.
The text has been added to the BPR. The animals will be vaccinated IM in the room.
The challenge will be given SC in the room on cart or table. Blood draws during the
vaccination and challenge phase will be performed on a cart or table if the animals
are anesthetized. If the animal is chair trained the vaccine might be give while the
animal is restrained in the chair and blood will be drawn while the animal is in the
chair. The chair would not fit in the BSC.
Contingency 3: Sections 5.7(b) and 5.11(d)- This indicates “tissue collections” but
5.7(b) does not indicate tissues will be collected. Please clarify by either checking
the appropriate boxes in 5.7(b) or removing “tissue collection” from 5.11(d).
INSTITUTIONAL BIOSAFETY COMMITTEE
Minutes, Page 4 of 4
Response: Section 5.11(d) has been updated and the “tissue collection” has been
removed.
- Next Meeting
The next Institutional Biosafety Committee meeting is scheduled for Thursday, 14 May 2026
at 11:15 in Birmingham. - Adjourn